Plain and Chromic Gut Absorbable Surgical Sutures recall: Endotoxin
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft…
Why was Plain and Chromic Gut Absorbable Surgical Sutures recalled?
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
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 (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)
- Product
- Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft…
- Recalling firm
- CP Medical Inc
- Quantity
- 1,905 boxes (22,860 sutures total)
- Distribution
- Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)