Z-1027-2019 Class II Ongoing
FDA device recall Z-1027-2019 was initiated by CP Medical Inc on February 4, 2019 and is designated Class II. Reason for recall: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. The recall status is ongoing. Affected quantity: 1,905 boxes (22,860 sutures total).
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,905 boxes (22,860 sutures total)
Product Description
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.
Reason for Recall
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Distribution Pattern
Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
Code Information
Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)