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Open, Classified

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.

FDA Recall Z-1027-2019 · Posted None

Recalling FirmCP Medical Inc
Recall StatusOpen, Classified
Product CodeGAL
Date Initiated2019-02-04
Product Quantity1,905 boxes (22,860 sutures total)

Reason for Recall

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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