Recall Z-0758-2007 ยท CCW Laryngoscope, Rigid
Teleflex Medical
Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; Distributed by Teleflex Medical, Research Triangle Park, NC 27709; catalog number 005852300
| Date | May 2, 2007 (initiated Mar 1, 2007) |
| Status | Terminated |
| Reason | The MRI Battery is out of specification for its magnetic content. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1 kit |
| Distribution | Georgia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062523 | TRU-MR LARYNGOSCOPE SET Truphatek International, Ltd., Nov 17, 2006 |