Device product
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. 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.
Z-0140-2015
Product summary
- Event
- Event 69373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74 boxes /12 sutures per box; plus an additional 13 sutures
- Official record key
device-enforcement:Z-0140-2015
Official wording
Reason: CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.
Code information: Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.
Distribution pattern: US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
Derived failure modes
-
Unknown
CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.