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C P Medical, Inc. recalls Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile.
Recalled November 5, 2014 · FDA recall Z-0140-2015 · C P Medical
Hazard
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. · FDA Class II
Units
74 boxes /12 sutures per box; plus an additional 13 sutures
Sold at
US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
Description
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.
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.
Manufacturer(s)
C P Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →