The Recall Desk
ModerateFDA (Devices)·Z-2119-2014·Announced 2014-08-06

Teleflex Medical Recalls Emerald Fiberoptic Blades Due to Packaging Error

Teleflex Medical is recalling 120 units of Emerald Fiberoptic Blades because the boxes contained incorrect Miller 4 blades instead of the labeled Macintosh 4 blades.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a packaging error where the wrong product was shipped. This fits the rubric for moderate severity, as it is a labeling/packaging issue without reported injuries or deaths.

Plain-English summary

Teleflex Medical is recalling 120 units of the Emerald Fiberoptic Blade, Macintosh 4, due to a packaging error. The recall was initiated after customers reported receiving the incorrect product. While the box labeling correctly indicated the Macintosh 4 blade, the contents of the boxes were found to be Miller 4 blades.

The affected products are distributed in the United States, specifically in the states of Florida, Georgia, Kentucky, Maryland, Mississippi, Montana, Pennsylvania, South Carolina, and Texas. The specific product code is 004434400 and the lot number is 02A1402138.

A rigid laryngoscope is a medical device used to examine and visualize a patient's upper airway and aid in the placement of a tracheal tube. Because the recalled items contain the wrong blade type, they may not function as intended for the specific airway visualization and intubation procedures for which the Macintosh 4 blade is designed. Healthcare facilities and customers should stop using the affected units and contact Teleflex Medical for instructions on returning the product.

The recalled product

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.
Manufacturer
Teleflex Medical
Affected units
120

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code: 004434400
  • Lot number: 02A1402138

Distribution

Distributed in 9 states: