Class II

Medical Device Recall: Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPARO

MEDLINE INDUSTRIES, LP - Northfield · March 22, 2024

Reason for Recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Product Description

Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

States Affected

NATIONWIDE

Quantity Affected

22891 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2704-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MEDLINE INDUSTRIES, LP - Northfield Medical Device Recall: Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPARO | SafeCheck