Reported Apr 7, 2021 · Terminated
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various…
Oscor, Inc.
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: Oscor, Inc. · 3816 Desoto Blvd · Palm Harbor, FL · 34683-1618
Is this the product you have?
- AngioDynamics SafeSheath ULTRALITE 10F
- Model Number VI10 - Product Usageintended for the introduction of various types of pacing leads and catheters
- Lot codes and dates
- GUDID
25051684026298Lot Number DP-11759
- GUDID
- Amount recalled
- 500 devices
Where it was sold
- Nationwide
- NY
Why it was recalled
Potential for open seal on sterile product
This product could cause temporary or reversible health problems — stop using it.
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