Maquet Pediatric Oxygenator Recalled for Incorrect Coating Labels on Packaging
Maquet is recalling 28 units of Quadrox-ID Pediatric Diffusion Membrane Oxygenators because the cartons and shipping containers incorrectly display Softline coating labels instead of Bioline.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error on the packaging (cartons and shipping containers) rather than the device itself, and no injuries or illnesses are reported. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 28 units of the Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Part Number BEQ-HMOD-30000. The recall was initiated after a customer complaint confirmed that while the oxygenators and their associated pouches are correctly labeled with the Bioline coating, the individual cartons and 4-pack shipping containers for this specific lot incorrectly bear Softline coating labels.
The affected product is identified by Lot number 70100610 and code k100278. The devices are intended for cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide, and adjust blood temperature. The recall is classified as Class II by the FDA.
The affected units were distributed in the District of Columbia, Massachusetts, and Michigan. Healthcare facilities and consumers who possess these specific units should stop using them and contact Maquet Cardiovascular US Sales, LLC for instructions on return or replacement.
The recalled product
- Product
- Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 28
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 (1)
- k100278 Lot number 70100610
Distribution
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