Reported Mar 27, 2019 · Ongoing
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are…
CP Medical 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: CP Medical Inc · 1775 Corporate Dr Ste 150 · Norcross, GA · 30093-2960
Is this the product you have?
- Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box
- Product UsagePlain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues
- Lot codes and dates
- Product Code (lot code)
822PG-HUF (170927-52180611-59)822PG-DAR (171205-52)810PG-1 (180924-51)822PG-1 (180924-53)
- Product Code (lot code)
- Amount recalled
- 1,905 boxes (22,860 sutures total)
Where it was sold
Why it was recalled
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
This product could cause temporary or reversible health problems — stop using it.
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