Medical Device Recall: Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the
Cook Incorporated · March 1, 2024
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Product Description
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
Distribution
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
States Affected
NATIONWIDE
Quantity Affected
1,493 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1531-2024
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.