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.
Recall
- Recall Number
- Z-2262-2013
- Event Number
- 66049
- Firm
- Maquet Cardiovascular Us Sales, Llc
- FEI Number
- 3008355164
- Product Code
- DTZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 15, 2013
- Posted
- September 20, 2013
- Terminated
- July 11, 2017
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470
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.
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.
Maquet sent a Urgent Product Recall letter/Response Form, dated 8/15/2013 via Fed Ex. On 8/26/2013 Maquet sent a letter to their customers informing them that all shipments of oxygenators and stainless steel hold clamps have been placed on a temporary hold due to an agency review in connection with FDA clearance. Customer service may be contacted at 1-888-627-8383, (option 2 followed by option 2) Monday though Friday between the hours of 8:00 am and 6:00 pm EST. Maquet issued a Certificate of Medical Neccesity (CMN) on September 17, 2013 to notify Quadrox customers that they may continue to receive and use their current inventory of Quadrox oxygenators and clamps by acknowledging the conditions provided in the CMN.
Worldwide Distribution, including Nationwide (US) and foreign countries.
1,182 units