Drug recall
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
FDA recall event 96332 · Class II · American Contract Systems Inc
Key facts
| Event ID | 96332 |
|---|---|
| Recall numbers | Z-1406-2025 |
| Recalling firm | American Contract Systems Inc |
| Product type | Devices |
| Products | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS… |
| Initiation date | Feb 4, 2025 |
| Report date | Mar 26, 2025 |
| City | Tiffin |
| State | OH |
| Country | United States |
| FEI number | 3008492337 |
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: