Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1325-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

stay-safe /Luer Lock Catheter Ext. 12 in

Product Classification:

Class I

Date Initiated: January 23, 2024

Date Posted: April 3, 2024

Recall Number: Z-1325-2024

Event ID: 94084

Reason for Recall:

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Status: Ongoing

Product Quantity: 663,221 eaches

Code Information:

Model Number: 050-95004; UDI/DI (Bag): 00840861100781; UDI/DI (Case): 10840861100788; All lots.

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated