Z-2174-2012 Class I Terminated
FDA device recall Z-2174-2012 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on July 18, 2012 and is designated Class I. Reason for recall: 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 … The recall status is terminated (terminated January 22, 2015). Affected quantity: 337,227 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2012
- Initiation Date
- July 18, 2012
- Termination Date
- January 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 337,227 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X. Product Distributed outside of the United States: 8FENJ lots 1003002176, 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.