FDA-Device2013-10-02Class II
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.
Maquet Cardiovascular Us Sales, Llc
Hazard
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.
Sold states
Worldwide Distribution, including Nationwide (US) and foreign countries.
Affected count
1,182 units
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2262-2013Don't want to check this manually?
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