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
FDA Recall Z-0758-2007 · Posted 2007-05-02
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCCW
Date Initiated2007-03-01
Date Terminated2007-05-03
Product Quantity1 kit
Reason for Recall
The MRI Battery is out of specification for its magnetic content.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Georgia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.