Plain and Chromic Gut Absorbable Surgical Sutures — Class II medical device recall Z-1027-2019
Ongoing recall by CP Medical Inc, reported 2019-03-27, distributed nationwide. Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test
| Recall number | Z-1027-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CP Medical Inc, Norcross, GA, United States |
| Recall initiated | 2019-02-04 |
| Classified | 2019-03-19 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
| Lot numbers | 810PG-1, 822PG-1, 822PG-DAR, 822PG-HUF |
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.
Reason for recall
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1027-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.