Recall Z-0655-2020 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
CP Medical Inc
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
| Date | Oct 18, 2019 |
| Status | Open, Classified |
| Reason | Failed to meet USP minimum average value for knot pull (tensile) strength. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures |
| Distribution | USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) Cp Medical, Aug 10, 2000 |