Z-1145-2021 Class II Terminated
FDA device recall Z-1145-2021 was initiated by Smiths Medical ASD Inc. on January 18, 2021 and is designated Class II. 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 … The recall status is terminated (terminated December 20, 2022). Affected quantity: 548 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 18, 2021
- Termination Date
- December 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 548 units
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.
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.
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.
Code Information
model 60PFS45, lots 3991171 (202 units), 3991172 (117 units), and 3988103 (229 units).