FDA-Device2014-11-05Class II
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.
C P Medical, Inc.
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.
Sold states
US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
Affected count
74 boxes /12 sutures per box; plus an additional 13 sutures
Manufactured in
803 NE 25th Ave, N/A, Portland, OR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0140-2015Don't want to check this manually?
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