CLASS II Device recall · Reported 2 Oct 2013 · FDA Enforcement Report
Quadrox iD Hmod 2030 Diffusion Membrane Oxygenator recalled
Maquet Cardiovascular Us Sales is recalling Quadrox iD Hmod 2030 Diffusion Membrane Oxygenator, distributed nationwide in the US. The recall was initiated on 15 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2262-2013
- FDA event ID
- 66049
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2013
- FDA classified
- 20 Sep 2013
- Reported
- 2 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Aug 2013 | Recall initiated by company | |
| 20 Sep 2013 | Classified by FDA | +36 days |
| 2 Oct 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Where it was distributed
Worldwide Distribution, including Nationwide (US) and foreign countries.
Questions about this recall
Is Quadrox iD Hmod 2030 Diffusion Membrane Oxygenator recalled?
Yes. Maquet Cardiovascular Us Sales recalled Quadrox iD Hmod 2030 Diffusion Membrane Oxygenator on 15 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2262-2013.
Why was it recalled?
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Which lots are affected?
QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
Where was it sold?
Worldwide Distribution, including Nationwide (US) and foreign countries.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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