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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients."
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…
- 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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