Reported May 14, 2014 · Terminated
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico.…
Teleflex Medical
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: Teleflex Medical · 4024 Stirrup Creek Dr · Durham, NC · 27703-9000
Is this the product you have?
- Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
- Lot codes and dates
- Product Code H5300 - Lot 1450153E13
- Amount recalled
- 32,271 ea.
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
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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