pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number

FDA device recall Z-0713-2014 · posted 2014-01-10 · Terminated

Recall details

Recalling firm: Radiometer America Inc
Reason for recall: RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.
Action taken: Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.
Root cause: Mixed-up of materials/components
Status: Terminated
Product code: CHL
Quantity affected: 209 boxes/6 membranes
Distribution: Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
Date initiated: 2013-06-10
Date posted: 2014-01-10
Date terminated: 2014-06-19
Location: Westlake, OH

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