—#183447

Product

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.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K083641, K914088
Affected lot / code info: Lot# 3952216

Why it was recalled

Label has the incorrect size for the tracheotomy tube.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US Distribution to state of: CT

Timeline

Recall initiated: 2020-08-28
Terminated: 2021-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.