Shiley Reusable Tracheostomy Tubes Recalled Due to Cannula Connection Issues
Nellcor Puritan Bennett Inc. is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes due to consumer complaints regarding the connections and functions of the inner and outer cannula.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used for airway management where functional defects could lead to harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling certain Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes. The affected model numbers include 8LPC and 8FEN for worldwide distribution, and 8FENJ, 8FENJ-S, 8LPC-S, and 8FEN-S for distribution outside the United States. The product is intended to bypass upper airway obstructions, provide long-term ventilation, and support or manage tracheal/bronchial secretions.
The recall was initiated due to consumer complaints related to the connections and functions of the inner and outer cannula, which were observed during the mechanical ventilation of patients. The source text does not specify the number of affected units, the specific dates of distribution, or whether any injuries or illnesses have been reported.
Healthcare providers and consumers should stop using the affected tracheostomy tubes and contact the manufacturer for further instructions. The packaging may indicate either Covidien or Tyco as the manufacturer, as the firm transitioned from Tyco to Covidien over the past four years.
The recalled product
- Product
- Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support an
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Affected units
- 337,227
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 (4)
- 1004000412
- and 120100433X. 8FEN-S lot 0910001010
- 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X
- and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.
Distribution
Distributed nationwide across the United States.
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