Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1145-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 18, 2021

Date Posted: March 3, 2021

Recall Number: Z-1145-2021

Event ID: 87192

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.

Status: Terminated

Product Quantity: 548 units

Code Information:

model 60PFS45, lots 3991171 (202 units), 3991172 (117 units), and 3988103 (229 units).

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated