Drug recall
stay-safe /Luer Catheter Ext. 6 in
FDA recall event 94084 · Class I · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 94084 |
|---|---|
| Recall numbers | Z-1323-2024, Z-1324-2024, Z-1325-2024, Z-1326-2024, Z-1327-2024 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | stay-safe /Luer Catheter Ext. 6 in, stay-safe /Luer Lock Adapter 4 in, stay-safe /Luer Lock Catheter Ext. 12 in, stay-safe /Luer Lock Catheter Ext. 18 in, stay-safe /Safe Lock Catheter Ext. 12 in |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Initiation date | Jan 23, 2024 |
| Report date | Apr 3, 2024 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
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: