Drug recall
Surgical Suture Kit
FDA recall event 90059 · Class II · Stradis Healthcare
Key facts
| Event ID | 90059 |
|---|---|
| Recall numbers | Z-1132-2022 |
| Recalling firm | Stradis Healthcare |
| Product type | Devices |
| Products | Surgical Suture Kit |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. |
| Initiation date | Apr 22, 2022 |
| Report date | Jun 1, 2022 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 1450943 |
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: