Reported Jun 11, 2014 · Terminated
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936.…
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 Avenue · Portland, OR · 97232-2304
Is this the product you have?
- 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
- Lot codes and dates
Lot 130826-08expiration 2015-07
- Amount recalled
- US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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