GETINGE US SALES LLC: Medical Device Recall in 2019 - (Recall #: Z-0677-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 13, 2019

Date Posted: December 18, 2019

Recall Number: Z-0677-2020

Event ID: 84352

Reason for Recall:

Sterile barrier system may be compromised

Status: Ongoing

Product Quantity: 3633 US

Code Information:

Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335 UDI Code: 04037691670164

Distribution Pattern:

Nationwide Canada

Voluntary or Mandated:

Voluntary: Firm initiated