CP Medical Recalls Coated PGA Sutures for Tensile Strength Failure
CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.
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, and the hazard involves a structural defect in a medical device used in surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
CP Medical Inc is recalling 2,124 units of Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm). The recall involves 174 boxes containing 12 sutures each, plus 36 samples. The specific product code is 494A/494A-IMC, with lot number 190123-59 and a manufacture date of 03/04/2019.
The recall was initiated because the product failed to meet the USP minimum average value for knot pull (tensile) strength. This defect means the sutures may not provide the required mechanical integrity during surgical use.
The product was distributed in the United States to the states of California, Ohio, Washington, Pennsylvania, Kentucky, Utah, Florida, Tennessee, South Carolina, Iowa, and Nebraska. Healthcare facilities and distributors should stop using the affected sutures and contact CP Medical Inc for further instructions.
The recalled product
- Product
- Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
- Manufacturer
- CP 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 (3)
- Product Code: 494A/494A-IMC
- Lot Number: 190123-59
- date of manufacture: 03/04/2019
Distribution
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