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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0758-2007
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
Status
Terminated
Initiated
2007-03-01
Posted
2007-05-02
Terminated
2007-05-03
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
Lot, serial or model codes
catalog number 005852300, battery lot numbers 065201-065228, 065231, 065232, 065233
510(k) numbers
["K062523"]
PMA numbers
not on file
Product code
CCW
Firm FEI
3004959265
Firm city
Bannockburn
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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