Class 2 Device Recall Plain gut sutures

• Date Initiated by Firm: February 04, 2019
• Create Date: March 19, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1027-2019
• Recall Event ID: 82197
• 510(K)Number: K001299
• Product Classification: Suture, absorbable, natural - Product Code GAL
• 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 tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
• Code Information: Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)
• FEI Number: 3012164473
• Recalling Firm/ Manufacturer: CP Medical Inc; 1775 Corporate Dr Ste 150; Norcross GA 30093-2960
• Manufacturer Reason for Recall: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
• FDA Determined Cause: Under Investigation by firm
• Action: CP Medical initially notified consignees via telephone call on about 02/01/2019. Consignees were gain notified via "URGENT: Recall Notice" via email on about 02/04/2019 and followed up with the same letter sent via FedEx on about 02/20/2019. Instructions included to immediately discontinue selling or using the affected product, return any affected product back to CP Medical, notify customers if the affected product was further distributed, and complete and return the "Recall Checklist." A request for a Returns Goods Authorization (RGA) and questions can be directed to Customer Service at 800-950-2763 and CP-CustomerService@cpmedical.com
• Quantity in Commerce: 1,905 boxes (22,860 sutures total)
• Distribution: Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GAL