Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter...
FDA Recall #Z-1531-2024 — Class II — March 1, 2024
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
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Recalling Firm
Cook Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,493 units
Distribution
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Code Information
Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2) JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3) JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 5) JCD8.0-38-20-HC (01)00827002102897(17) 15761259
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.