FDA Device recall Z-1027-2019
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box
- FDA Device
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box by Cp Medical, citing potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1027-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-04 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cp Medical |
| Distribution | US |
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
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Identifiers
| code_info | Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1027-2019%22
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