Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc
FDA device recall Z-2417-2015 · posted 2015-08-19 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
- Action taken
- Radiometer sent a Product Notification letter dated July 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In the letter the firm requests that inventory be checked and removed for any the identified lot numbers for Fixation kit N20. The firm requests that the products be discarded. The letter states to complete p.2 and return it to their Radiometer representative. If you have any questions contact Radiometer America Technical Support at 1-800-736-0600 opt.4.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 4244 kits
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Canada, Spain, France, Great Britain, Philippines, Netherlands, Japan, China, Australia, Denmark, South Africa, Germany, Qatar, Turke
- Date initiated
- 2015-07-16
- Date posted
- 2015-08-19
- Date terminated
- 2016-01-29
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (K093154) | Radiometer Medical Aps | 2010-02-05 |