Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
- Company
- Cp Medical Inc
- Recall Initiated
- October 18, 2019
- Recall Number
- Z-0655-2020
- Quantity
- 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
- Firm Location
- Norcross, GA
Reason for Recall
Failed to meet USP minimum average value for knot pull (tensile) strength.
Distribution
USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Lot / Code Info
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
Root Cause
Under Investigation by firm
Action Taken
Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.