Z-1027-2019Class II

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box

Name: Z-1027-2019 Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box
Creator: CP Medical Inc
Published: 2019-02-04
License: https://open.fda.gov/license/

Cp Medical / initiated 2019-02-04 / Open, Classified / root cause: sterility

FDA source

CP Medical Inc began a recall of 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... on 2019-02-04. FDA classified it as Class II and gives the reason as "Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1027-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-04
Posted: 2019-03-19
Recalling firm: Cp Medical
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.
Product code: GAL Suture, Absorbable, Natural
Reason for recall: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Root cause tag: sterility
FDA 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 [email protected]
Quantity in commerce: 1,905 boxes (22,860 sutures total)
Distribution: Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
Product codes and lots: Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1027-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1027-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-19

Product code GAL

K001299Class IIPlain and Chromic Gut Absorbable Surgical Sutures UspCp Medical / cleared 2000-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)