D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
FDA device recall Z-1436-06 · posted 2006-08-31 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- KLK
- Quantity affected
- 3,323-USA, 1,197-Foreign
- Distribution
- 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, V
- Date initiated
- 2005-11-01
- Date posted
- 2006-08-31
- Date terminated
- 2012-04-25
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TCM400 (K001866) | Radiometer Medical A/S | 2000-12-07 |