Reported Jun 26, 2019 · Terminated
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND…
Ethicon, 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: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm
- USP1 Single Armed CTX Product CodeX865W
- Product UsageETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
- Lot codes and dates
- Lot CodePBQ797
- Amount recalled
- 36 eaches
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
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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