Recall Z-0726-2021— Smiths Medical ASD Inc.

Name: FDA recall Z-0726-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-12-15, terminated 2022-12-20. It names one FDA 510(k) clearance: K944178. Product: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45. Reason: A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-15
Terminated: 2022-12-20
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESBivona Medical Technologies·cleared 1994-10-27

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

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Reason for recall

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

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