Reported Sep 21, 2016 · Terminated
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
C.R. Bard, 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: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
- Lot codes and dates
- Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461
- Exp Date08/01/2016
- Amount recalled
- 274 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
This product could cause temporary or reversible health problems — stop using it.
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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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