Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CP Medical Inc
- Reason for Recall:
- Failed to meet USP minimum average value for knot pull (tensile) strength.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Product Codes/Lot Numbers:
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
Distribution:
Distributed in: CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0655-2020
Related Recalls
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.