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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
Recall Number Z-0713-2014
Classification Class II
Code Info Part #: 942-042, Lot #: R0971
Product Distributed Qty 209 boxes/6 membranes
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.

Event Detail

Event Id 67044
Product Type Devices
Status Ongoing
Recalling Firm Radiometer America Inc
City Westlake
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
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