Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with
FDA device recall Z-1225-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.
- Action taken
- Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- CCW
- Quantity affected
- 1,408 laryngoscopes
- Distribution
- Nationwide and Canada, Colombia, Costa Rica and Chile.
- Date initiated
- 2006-06-15
- Date posted
- 2006-07-13
- Date terminated
- 2009-08-28
- Location
- Bannockburn, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LARYNGOSCOPE BLADES (K883414) | Truphatek, Ltd. | 1988-08-19 |