Drug recall
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut…
FDA recall event 82197 · Class II · CP Medical Inc
Key facts
| Event ID | 82197 |
|---|---|
| Recall numbers | Z-1027-2019 |
| Recalling firm | CP Medical Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. |
| Initiation date | Feb 4, 2019 |
| Report date | Mar 27, 2019 |
| City | Norcross |
| State | GA |
| Country | United States |
| FEI number | 3012164473 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: