Reported Nov 5, 2014 · Terminated
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile.…
C P Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C P Medical, Inc. · 803 NE 25th Ave · Portland, OR · 97232-2304
Is this the product you have?
- 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.
- Lot codes and dates
Product Lot Number (s) Code L345130618-12. L346140304-14. L463130513-16. L923130729-17140127-02. L942140117-03140128-06
- Amount recalled
- 74 boxes /12 sutures per box; plus an additional 13 sutures
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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