Smiths Medical ASD Inc. PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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."