Recall Z-2174-2012— Nellcor Puritan Bennett Inc. (dba Covidien LP)

Name: FDA recall Z-2174-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Class I · Terminated

Class I FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2012-07-18, terminated 2015-01-22. It names one FDA 510(k) clearance: K962173. 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.. Reason: 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..

Recalling firm: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Classification: Class I
Status: Terminated
Initiated: 2012-07-18
Terminated: 2015-01-22
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESMallinckrodt Medical·cleared 1996-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.