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Recall Observatory FDA recall evidence

Device product

Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Z-2119-2014

July 09, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 68757
Status
Terminated
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-2119-2014

Official wording

Reason: Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.

Code information: Product Code: 004434400, Lot number: 02A1402138

Distribution pattern: US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Packaging Error