Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Mag
FDA device recall Z-0758-2007 · posted 2007-05-02 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The MRI Battery is out of specification for its magnetic content.
- Action taken
- Teleflex telephoned the account on 3/1/07, and faxed them a follow-up recall letter on the same date. The account was informed that the batteries did not meet specification, and was requested to check the batteries in the laryngoscope kit shipped to them for the affected battery lot numbers, and return the affected batteries to Teleflex for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CCW
- Quantity affected
- 1 kit
- Distribution
- Georgia
- Date initiated
- 2007-03-01
- Date posted
- 2007-05-02
- Date terminated
- 2007-05-03
- Location
- Bannockburn, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRU-MR LARYNGOSCOPE SET (K062523) | Truphatek International, Ltd. | 2006-11-17 |