Device Recall pO2 D999 membrane units 의 리콜

Recall

67044

Class 2

Z-0713-2014

2013-06-10

2014-01-10

Terminated

United States

2014-06-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124601

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.

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.