Recall Z-1708-2014 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
C P Medical Inc.
Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle
| Date | Jun 3, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength. |
| Root cause | Employee error |
| Action | CP Medical, Inc., sent a Recall Notice letter dated April 28, 2014 to affected customers. The letter identified the affect product, problem and actions to be taken. The letter instructed customers to immediately discontinue selling or using the recalled product and return all existing stock to CP Medical. They also request their customers to contact downstream customers and request that all their existing stock be returned. CP Medical, Inc. asks all customers to provide them with information as to the quantity of recalled product they are able to return and for all stock they are no |
| Quantity | US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total). |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030786 | MONO-SWIFT Cp Medical, May 6, 2003 |