Reported Nov 23, 2016 · Terminated
Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length…
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?
- Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture
- ManufacturerC.R. Bard, Inc., Covington, GA 30014
- Lot codes and dates
- Product Codes
777400777600777700777800778400778600778700778800786400786600786700786800787400787600787700787800788400788600788700 and 788800
- Product Codes
- Amount recalled
- 75,089 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
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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