Recall Z-1951-2015— Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Name: FDA recall Z-1951-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Class I · Terminated

Class I FDA medical device recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), initiated 2015-05-08, terminated 2017-04-12. It names one FDA 510(k) clearance: K122531. Product: Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.. Reason: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels..

Recalling firm: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Classification: Class I
Status: Terminated
Initiated: 2015-05-08
Terminated: 2017-04-12
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K122531 — SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TCovidien·cleared 2012-10-09

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 Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

Reason for recall

Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

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