Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
This recall has been terminated (originally issued May 28, 2015).
- Recall Initiated
- March 5, 2015
- Posted
- May 28, 2015
- Terminated
- January 18, 2019
- Recall Number
- Z-1689-2015
- Quantity
- 10,199 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
Distribution
Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia Montenegro, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and Uruguay
Lot / Code Info
Part numbers BO-HMOD 70000, 70105.3815, BEQ-HMOD 70000, 70105,3824
Root Cause
Nonconforming Material/Component
Action Taken
Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to fieldactions@maquet.com. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.