Z-0758-2007

Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for...

Name: Z-0758-2007 Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for...
Creator: Teleflex Medical
Published: 2007-03-01
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2007-03-01 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments... on 2007-03-01. The reason FDA records is "The MRI Battery is out of specification for its magnetic content". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0758-2007
Status: Terminated
Initiated: 2007-03-01
Posted: 2007-05-02
Terminated: 2007-05-03
Recalling firm: Teleflex Medical
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
Product code: CCW Laryngoscope, Rigid
Reason for recall: The MRI Battery is out of specification for its magnetic content.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 kit
Distribution: Georgia
Product codes and lots: catalog number 005852300, battery lot numbers 065201-065228, 065231, 065232, 065233

Product code CCW

K062523Class ITru-Mr Laryngoscope SetTruphatek International, Ltd. / cleared 2006-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)