D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
FDA Recall Z-1436-06 · Posted 2006-08-31
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeKLK
Date Initiated2005-11-01
Date Terminated2012-04-25
Product Quantity3,323-USA, 1,197-Foreign
Reason for Recall
Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
Firm Action
The firm decided to initiate a recall on 9/8/2005 and the recall letter was issued in November, 2005. The letter informs the customers of this problem and asks that each customer inspect their current stock for the presence of the recalled lot codes and discard any such product found. The letter is accompanied by a recall response form which the customer can use to request additional replacement ellectrodes as necessary.
Root Cause
Other
Distribution Pattern
Worldwide distribution --- including the states of PA, IL, TX, NY, FL, KS, NE, AL, MI, LA, WI, MN, NJ, CA, NH, MD, OH, MO, UT, IN, GA, WA, MA, KY, NC, IA, OK, SD, CO, AR, SC, ME, NV, AZ, RI, AK, MS, VA, WV, MT, TN, IN & NM. Country List pending
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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