The Recall Desk
ModerateFDA (Devices)·Z-1938-2016·Announced 2016-06-15

Teleflex Recalls Sterile Tracheal Tubes Due to Size Labeling Error

Teleflex Medical is recalling 6,390 sterile tracheal tubes because some units labeled as 7mm may actually be 7.5mm.

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 labeling error regarding product size, which fits the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Teleflex Medical is recalling 6,390 units of Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tubes, Reference V5-10314, ID 7.0 mm. The recall is due to a labeling error where some units indicate a size 7mm tracheal tube but may contain a size 7.5mm tracheal tube.

The affected product is Lot 73F1500606. These tracheal tubes are used for airway management by being inserted into a patient's mouth or nose. The recall covers units distributed to the states of AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX, and UT.

Healthcare providers should check their inventory for this specific lot number and reference. If the product is found, it should be removed from use and returned to Teleflex Medical according to their instructions.

The recalled product

Product
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.
Manufacturer
Teleflex Medical
Affected units
6,390

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 (1)

  • Lot 73F1500606

Distribution