Z-0870-2015Class II

Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000...

Name: Z-0870-2015 Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2014-11-05
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2014-11-05 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung... on 2014-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0870-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Posted: 2014-12-24
Terminated: 2015-07-24
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.
Quantity in commerce: 28 units
Distribution: Distributed in DC, MA, & MI.
Product codes and lots: k100278 Lot number 70100610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0870-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0870-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code DTZ

K100278Class IIQuadrox-Id Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models Be-Hmod 30000-USA, Beq-Hmod 30000-USAMaquet Cardiopulmonary, AG / cleared 2010-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)