FDA Device recall Z-2262-2013
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator by Maquet Cardiovascular Us Sales, citing 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 sp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2262-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-15 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2262-2013%22
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