Z-1145-2021Class II

Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model...

Name: Z-1145-2021 Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model...
Creator: Smiths Medical ASD Inc.
Published: 2021-01-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-01-18 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck... on 2021-01-18. FDA classified it as Class II and gives the reason as "Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1145-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-18
Posted: 2021-02-23
Terminated: 2022-12-20
Recalling firm: Abbott Medical
Product: Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Distribution of the "URGENT MEDICAL DEVICE RECALL NOTICE" dated 01/29/2021 during the week of January 18, 2021.
Quantity in commerce: 548 units
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.
Product codes and lots: model 60PFS45, lots 3991171 (202 units), 3991172 (117 units), and 3988103 (229 units).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1145-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1145-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-23

Product code JOH

K944178Class IIBivona Flextend Pediatric & Neonatal Tracheostromy TubesBivona Medical Technologies / cleared 1994-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)