FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
- Recall number
- Z-0726-2021
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
- Status
- Terminated
- Initiated
- 2020-12-15
- Posted
- not on file
- Terminated
- 2022-12-20
- 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.
- Root cause
- Packaging process control
- Action
- The firm initiated the recall by letter on 12/15/2020. The letter requested the following: "INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS: 1. Locate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice. 2. Determine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession. 3. All affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX. 4. Product credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed. 5. DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately."
- Quantity
- 238 devices
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot Number 3991195
- 510(k) numbers
- ["K944178"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28