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

Is my product affected?

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

• UPC 04037691670164

Check against the official notice below — it lists the full affected range.

What happened

Getinge US Sales LLC is recalling Maquet Cardiopulmonary Quadrox-iD Pediatric Diffusion Membrane Oxygenators with Bioline Coating (model BEQ-HMOD 30000) distributed nationwide in Canada and in the United States. The recall affects 3,633 units across multiple lot codes because the sterile barrier system may be compromised, which could affect the sterile condition of the device.

The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Sterile barrier system may be compromised

Details from the source

Reason for recall: Sterile barrier system may be compromised Distribution: Nationwide Canada Quantity: 3633 US Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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