Getinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility failure in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Getinge US Sales LLC is recalling 3,633 units of the Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile (REF: BEQ-HMOD 30000). The recall was initiated because the sterile barrier system may be compromised.
The affected units were distributed nationwide in the United States and in Canada. Specific lot codes and the UDI code 04037691670164 are listed in the official recall documentation.
Healthcare facilities should check their inventory for the specific lot codes and UDI code listed in the recall notice. If the product is found, it should be removed from use and returned to Getinge US Sales LLC according to their instructions.
The recalled product
- Product
- Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
- Manufacturer
- GETINGE US SALES LLC
- Category
- Medical Device — Cardiopulmonary
- Hazard
- Affected units
- 3,633
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot codes: 70114704
- 70120471
- 70123847
- 70123854
- 70124528
- 70124693
- 70127336
- 70130216
- 70123853
- 70129395
- 7011472 05
- 70121444
- 70123849
- 70124474
- 70124529
- 70124694
- 70127498
- 70131871
- 70124527
- 70113694
Distribution
Distributed nationwide across the United States.
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