Recall Z-0802-2025— Greiner Bio-One GmbH

Name: FDA recall Z-0802-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Class II · Ongoing

Class II FDA medical device recall by Greiner Bio-One GmbH, initiated 2024-11-19. It names one FDA 510(k) clearance: K180545. Product: VACUETTE SAFELINK, REF: 450210. Reason: The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device..

Recalling firm: Greiner Bio-One GmbH
Classification: Class II
Status: Ongoing
Initiated: 2024-11-19
Firm location: Kremsmunster, Austria

510(k) clearances named in this recall

1 on FDA's record

K180545 — VACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc.·cleared 2018-05-21

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

VACUETTE SAFELINK, REF: 450210

Reason for recall

The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

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