Smiths Medical ASD Inc. Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Label has the incorrect size for the tracheotomy tube.

Recommended Action

Per FDA guidance

On 08/28/20, the firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" to its consignees. The consignee was instructed to follow: INSTRUCTIONS TO CUSTOMERS: 1. Locate and quarantine the affected Bivona Mid-Range Aire-Cuf Tracheostomy Tubes in your possession by referring to the attached Urgent Medical Device Recall Response Form. This form identifies the one (1) specific lot number and quantity distributed to your facility. ONLY UNUSED PRODUCT SHOULD BE QUARANTINED FOR RETURN. 2. Complete the attached Urgent Medical Device Recall Form within 10 days of receipt and return it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected product in your possession. Product credit will be processed once the Urgent Medical Device Field Recall Response Form is received. 3. All affected product must be returned to Compliance at Smiths Medical for processing. Pre-paid shipping labels will be sent once you have returned the completed response form attached with this notice. Include a copy of your completed Response Form inside the package of returned product to facilitate processing. Make sure packages are sealed and labeled with your facility name prior to shipping to Smiths Medical. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com.

Distribution

As reported by FDA

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