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.
Reported: October 2, 2013 Initiated: August 15, 2013 #Z-2262-2013
Product Description
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 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.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 1,182 units
- Distribution
- Worldwide Distribution, including Nationwide (US) and foreign countries.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 1,182 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2013. Severity: Moderate. Recall number: Z-2262-2013.
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