—#50930

Product

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 product code: CCW — Laryngoscope, Rigid
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K062523
Affected lot / code info: catalog number 005852300, battery lot numbers 065201-065228, 065231, 065232, 065233

Why it was recalled

The MRI Battery is out of specification for its magnetic content.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Georgia

Timeline

Recall initiated: 2007-03-01
Posted by FDA: 2007-05-02
Terminated: 2007-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.