CLASS I ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
stay-safe /Safe Lock Catheter Ext recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling stay-safe /Safe Lock Catheter Ext, distributed nationwide in the US. The recall was initiated on 23 Jan 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1323-2024
- FDA event ID
- 94084
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Jan 2024
- FDA classified
- 26 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Jan 2024 | Recall initiated by company | |
| 26 Mar 2024 | Classified by FDA | +63 days |
| 3 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Product as listed by the FDA
stay-safe /Safe Lock Catheter Ext. 12 in
Where it was distributed
Domestic: Nationwide Distribution.
Questions about this recall
Why was it recalled?
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Which lots are affected?
Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
Where was it sold?
Domestic: Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 94084This product is part of a recall event; the main page for the event is stay-safe /Luer Lock Adapter recalled by Fresenius Medical Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | stay-safe /Luer Lock Adapter recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS I | stay-safe /Luer Lock Catheter Ext recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS I | stay-safe /Luer Catheter Ext recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS I | stay-safe /Luer Lock Catheter Ext recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
More recalls from Fresenius Medical Care Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |