| Class 2 Device Recall Lactate Membrane units |  |
Date Initiated by Firm | October 08, 2012 |
Date Posted | September 30, 2013 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number | Z-2303-2013 |
Recall Event ID |
66108 |
510(K)Number | 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 OH 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 | 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 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 = KHP 510(K)s with Product Code = KHP
|
|
|
|