Recall Z-1225-06 ยท CCW Laryngoscope, Rigid
Teleflex Medical
Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
| Date | Jul 13, 2006 (initiated Jun 15, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 1,408 laryngoscopes |
| Distribution | Nationwide and Canada, Colombia, Costa Rica and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883414 | LARYNGOSCOPE BLADES Truphatek, Ltd., Aug 19, 1988 |