FDA Medical Device Recalls (openFDA)
CP Medical Inc: 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.
- Recall number
- Z-1027-2019
- Recalling firm
- CP Medical Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2019-02-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
- Root 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
- 1,905 boxes (22,860 sutures total)
- Distribution
- Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
- Lot, serial or model codes
- Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)
- 510(k) numbers
- ["K001299"]
- PMA numbers
- not on file
- Product code
- GAL
- Firm FEI
- 3012164473
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28