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U.S. Department of Health and Human Services

Class 2 Device Recall Lactate Membrane units

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 Class 2 Recall
Lactate Membrane units
see related information
Date Posted September 30, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-2303-2013
Recall Event ID 66108
Premarket Notification
510(K) Numbers
K002290  K043218 
Product Classification Acid, Lactic, Enzymatic Method - Product Code KHP
Product Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Code Information Part Number: 942-066 R1741 to R1869
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake, Ohio 44145-1521
For Additional Information Contact Matthew R. Ackerman
440-871-8900 Ext. 53485
Manufacturer Reason
for Recall
RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 11/07/2012, the firm sent "Urgent Field Safety Notices to their customers. The product issue was described and recommended actions were provided. Customers may contact 1 (800) 736-0600, option 4 if questions.
Quantity in Commerce 13,632 boxes/4 membranes
Distribution Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KHP and Original Applicant = RADIOMETER MEDICAL A/S
510(K)s with Product Code = KHP and Original Applicant = RADIOMETER MEDICAL APS
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