Maquet Quadrox-ID Pediatric Diffusion Membrane recall
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a…
Why was Maquet Quadrox-ID Pediatric Diffusion Membrane recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
k100278 Lot number 70100610
- Product
- Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 28 units
- Distribution
- Distributed in DC, MA, & MI.
- Recall date
- December 31, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)