FDAFDA · Food and drugs·Recall number Z-0677-2020
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Published December 18, 2019 · Recall initiated: November 13, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterile barrier system may be compromised
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GETINGE US SALES LLC
- Distributor
- Nationwide Canada
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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