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Recall Observatory FDA recall evidence

Device product

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

Z-0726-2021

December 15, 2020

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 86954
Status
Terminated
Classification
Class II
Quantity
238 devices
Official record key
device-enforcement:Z-0726-2021

Official wording

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.

Code information: Lot Number 3991195

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.