Drug recall
Non-sterile procedural trays labeled as CRANI, 2 per case
FDA recall event 91387 · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Event ID | 91387 |
|---|---|
| Recall numbers | Z-1029-2023, Z-1030-2023, Z-1031-2023, Z-1032-2023, Z-1033-2023, Z-1034-2023, Z-1035-2023 |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Product type | Devices |
| Products | Non-sterile procedural trays labeled as CRANI, 2 per case, Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case, Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case, Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case, Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| Initiation date | Nov 17, 2022 |
| Report date | Feb 8, 2023 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 1–9 Products in this recall
- 10–99 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: