FDAFDA · Food and drugs·Recall number Z-1528-2024
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Published April 24, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Lot
- UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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