FDA Enforcement
Class II
Ongoing
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Recall: Z-0677-2020
·
Reported December 18, 2019
Enforcement
- Recall Number
- Z-0677-2020
- Event ID
- 84352
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GETINGE US SALES LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2019
- Initiation Date
- November 13, 2019
- Classification Date
- December 12, 2019
- Address
- 45 BARBOUR POND DR, N/A, WAYNE, NJ, 07470, United States
Description
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
Code Info
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
Nationwide Canada
Quantity
3633 US