CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure
CP Medical is recalling one lot of Monoswift PGCL absorbable sutures because they failed to meet USP minimum tensile strength requirements.
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 involves a medical device with a functional defect (tensile strength) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CP Medical, Inc. is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Sutures. The specific lot affected is 130826-08, with an expiration date of July 2015. The product is labeled sterile and consists of undyed, monofilament synthetic absorbable sutures with needles, USP size 3/0 (2.0 metric), part number L936.
The recall was initiated because the sutures failed to meet the USP minimum average value for knot pull (tensile) strength. This defect could potentially affect the performance of the suture during surgical procedures.
The affected product was distributed worldwide, including nationwide distribution in the United States. In the US, 48 total sutures (4 boxes of 12) were distributed, while 528 total sutures (44 boxes of 12) were distributed outside the US. Healthcare facilities and consumers should stop using the affected lot and contact CP Medical for further instructions.
The recalled product
- Product
- 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 s
- 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 (2)
- Lot 130826-08
- expiration 2015-07.
Distribution
Distributed nationwide across the United States.
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