Z-0655-2020 Class II Ongoing
FDA device recall Z-0655-2020 was initiated by CP Medical Inc on October 18, 2019 and is designated Class II. Reason for recall: Failed to meet USP minimum average value for knot pull (tensile) strength. The recall status is ongoing. Affected quantity: 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
Product Description
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Reason for Recall
Failed to meet USP minimum average value for knot pull (tensile) strength.
Distribution Pattern
USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Code Information
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019