QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator recall
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators…
Why was QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 1,182 units
- Distribution
- Worldwide Distribution, including Nationwide (US) and foreign countries.
- Recall date
- October 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)