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Z-2262-2013Class II

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD...

Maquet Cardiovascular Us Sales, LLC / initiated 2013-08-15 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Maquet Cardiovascular Us Sales, Llc began a recall of QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2262-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Maquet Cardiovascular Us Sales, LLC
Product
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.
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
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.
Quantity in commerce
1,182 units
Distribution
Worldwide Distribution, including Nationwide (US) and foreign countries.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2262-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2262-2013Class IITerminatedVoluntary: Firm initiated