Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0005-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Product Classification:

Class I

Date Initiated: August 8, 2023

Date Posted: October 18, 2023

Recall Number: Z-0005-2024

Event ID: 92906

Reason for Recall:

There is a potential for blood backfill leakage and foreign material.

Status: Ongoing

Product Quantity: 124,773 boxes total

Code Information:

UDI-DI: 16945060501122; All Lots

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated