Recall Z-0007-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0007-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Class I · Ongoing

Class I FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2023-08-08. It names one FDA 510(k) clearance: K050999. Product: 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case. Reason: There is a potential for blood backfill leakage and foreign material..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-08-08
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K050999 — YI XIN STERILE SYRINGE FOR SINGLE USEJiangxi Sanxin (Eversincere) Medical Devices Group·cleared 2005-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.