Maquet Cardiovascular Us Sales, Llc 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. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Maquet Cardiovascular Us Sales, Llc
Lot Codes / Batch Numbers
k100278 Lot number 70100610
Products Sold
k100278 Lot number 70100610
Maquet Cardiovascular Us Sales, Llc is recalling Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD due to Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membra. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MA, MI, DC
Page updated: Jan 10, 2026