Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 5,201–5,250 of 8,689
- Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120ASurgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Class II
Medical Device Recall · November 6, 2024
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artDue to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
- Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V;Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Class II
Medical Device Recall · November 6, 2024
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Class II
Medical Device Recall · November 6, 2024
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure ofBD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
- Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Class II
Medical Device Recall · November 6, 2024
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Class II
Medical Device Recall · November 6, 2024
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Class II
Medical Device Recall · November 6, 2024
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography sysGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed ElGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound TherDue to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HDGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systemsGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systemsGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOXRed button used to engage side rails can break or become stuck making it difficult to engage the side rail.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CTGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systemsGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 5, 2024
Microscissor Tip (Disposable); Microline Catalog #: 3122.A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
- Class II
Medical Device Recall · November 5, 2024
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography systemGE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Class II
Medical Device Recall · November 4, 2024
dS Breast 16ch 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
ST SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Mammotrak Diagnostic Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
dS Breast 7ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
ST SENSE Breast Dx CoilPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Achieva TX Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Mammotrak Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Mammotrak Interventional Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
SENSE Breast Coil 3.0T 7chPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession andVirtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
- Class II
Medical Device Recall · November 4, 2024
dS Breast 16ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Mammotrak Diagnostic Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
dS Breast 7ch 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan.
- Class II
Medical Device Recall · November 4, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
- Class II
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, andOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
- Class II
Medical Device Recall · November 1, 2024
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XLIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
- Class II
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
- Class I
Medical Device Recall · November 1, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITEDue to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).