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Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FE
Recalled August 22, 2012 · FDA recall Z-2174-2012 · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Hazard
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. · FDA Class I
Units
337,227 units
Sold at
Worldwide Distribution - US Nationwide
Description
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.
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 and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
Manufacturer(s)
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →