Reported Apr 24, 2024 · Ongoing
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- 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
- G01844DTVN-5.0-19-10.0-
- YUEHG09490
- Lot codes and dates
- UDI-DI/Lot Number1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532
- Amount recalled
- 55 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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