Coated PGA Undyed Polyglycolic Acid Braided Absorbable recall
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Why was Coated PGA Undyed Polyglycolic Acid Braided Absorbable recalled?
Failed to meet USP minimum average value for knot pull (tensile) strength.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
- Product
- Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
- Recalling firm
- CP Medical Inc
- Quantity
- 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
- Distribution
- USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)