Device 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.
Z-2262-2013
Product summary
- Event
- Event 66049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,182 units
- Official record key
device-enforcement:Z-2262-2013
Official wording
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.
Code information: 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
Distribution pattern: Worldwide Distribution, including Nationwide (US) and foreign countries.
Derived failure modes
-
Potency or specification failure
may not meet specifications