Z-0677-2020 Class II Ongoing
FDA device recall Z-0677-2020 was initiated by GETINGE US SALES LLC on November 13, 2019 and is designated Class II. Reason for recall: Sterile barrier system may be compromised The recall status is ongoing. Affected quantity: 3633 US.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 13, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3633 US
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
Distribution Pattern
Nationwide Canada
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