Recall Z-0677-2020— GETINGE US SALES LLC

Name: FDA recall Z-0677-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-13

Class II · Ongoing

Class II FDA medical device recall by GETINGE US SALES LLC, initiated 2019-11-13. It names one FDA 510(k) clearance: K100278. Product: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000. Reason: Sterile barrier system may be compromised.

Recalling firm: GETINGE US SALES LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-11-13
Firm location: WAYNE, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K100278 — QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USAMaquet Cardiopulmonary, AG·cleared 2010-04-30

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

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

Reason for recall

Sterile barrier system may be compromised

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