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
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
Packaging Error