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U.S. Department of Health and Human Services

Class 2 Device Recall pO2 D999 membrane units

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  Class 2 Device Recall pO2 D999 membrane units see related information
Date Initiated by Firm June 10, 2013
Date Posted January 10, 2014
Recall Status1 Terminated 3 on June 19, 2014
Recall Number Z-0713-2014
Recall Event ID 67044
510(K)Number K895181  K922922  K935655  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product 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).
Code Information Part #: 942-042, Lot #: R0971
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information Contact
440-871-8900 Ext. 209
Manufacturer 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action 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.
Quantity in Commerce 209 boxes/6 membranes
Distribution Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER AMERICA, INC.
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