CP Medical Recalls PGCL Absorbable Sutures Due to Tensile Strength Failure
CP Medical Inc is recalling PGCL absorbable sutures because they failed to meet USP 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 involves a medical device with a performance defect (tensile strength) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
CP Medical Inc is recalling PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures. The recall involves 504 boxes containing 6,048 individual sutures. The affected product codes are L923, L459, L493, L762, L463, L922, L495, L497, and L494. The specific lot numbers are 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, and 160824-50.
The recall was initiated because the tensile strength minimum required by USP <881> was not met over the length of the product's shelf life. This defect could potentially affect the performance of the sutures during medical procedures.
The affected sutures were distributed in the following states: AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, and WA, as well as in South Africa. Healthcare providers and facilities should stop using the affected sutures and contact CP Medical Inc for further instructions.
The recalled product
- Product
- PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
- Manufacturer
- CP Medical Inc
- Category
- Medical Device — Sutures
- 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 (11)
- Lot Numbers - 150323-04
- 150324-04
- 150520-10
- 150615-01
- 150616-08
- 150709-01
- 151229-64
- 160414-69
- 160510-59
- 160617-52
- 160824-50
Distribution
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