Reported Feb 27, 2019 · Terminated
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other…
Boston Scientific Corporation
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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- Lot codes and dates
Material Number (UPN) H749M3004A0Batch Number 21558994Expiration Date 11/30/2019
- Amount recalled
- 49 units
Where it was sold
Why it was recalled
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
This product could cause temporary or reversible health problems — stop using it.
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