CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure
CP Medical is recalling five lots of Monoswift PGCL absorbable surgical sutures because they failed to meet minimum tensile strength requirements over their shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failing to meet minimum tensile strength standards, which poses a risk of harm (suture breakage) during surgery, but the source text does not report any specific injuries or illnesses.
Plain-English summary
CP Medical, Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Sutures, USP size 3/0. The product is an undyed, monofilament synthetic absorbable suture with a needle size of 3/0, labeled as sterile and sealed in an inner foil pouch with an outside Tyvek pouch.
The recall was initiated because the sutures failed to meet the minimum tensile strength as dictated by the United States Pharmacopeia (USP) over the length of the product's shelf life. The affected lots are L345, L346, L463, L923, and L942, with specific expiration codes listed in the agency's records.
The recall involves 74 boxes (containing 12 sutures each) plus an additional 13 individual sutures. These products were distributed in the United States, specifically in the states of Arkansas, Arizona, California, Florida, Maine, Michigan, Nebraska, Oregon, South Carolina, and Washington. Healthcare facilities and distributors should stop using the affected sutures and contact CP Medical for instructions on return or replacement.
The recalled product
- 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
- C P Medical, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
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