FDA-Device2019-03-27Class II
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain 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.
CP Medical Inc
Hazard
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Sold states
Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
Affected count
1,905 boxes (22,860 sutures total)
Manufactured in
1775 Corporate Dr Ste 150, N/A, Norcross, GA, United States
Products
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief