FDA Device recall Z-1327-2024
stay-safe /Luer Catheter Ext. 6 in
- FDA Device
- Class I
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class I recall of stay-safe /Luer Catheter Ext. 6 in by Fresenius Medical Care Holdings, citing the peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1327-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-01-23 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
stay-safe /Luer Catheter Ext. 6 in
Reason
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Identifiers
| code_info | Model Number: 050-95013; UDI/DI (Bag): 00840861100804; UDI/DI (Case): 10840861100801; All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2024%22
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