Device product
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.
Z-1027-2019
Product summary
- Firm
- CP Medical Inc
- Event
- Event 82197
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,905 boxes (22,860 sutures total)
- Official record key
device-enforcement:Z-1027-2019
Official wording
Reason: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Code information: Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)
Distribution pattern: Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
Derived failure modes
-
Unknown
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.