—#153205

Product

Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K083641
Affected lot / code info: 3272963

Why it was recalled

Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Consignees were sent a Smiths Medical "Urgent Medical Device Field Safety Notice" dated February 08, 2017. The letter was addressed to "Clinician". The letter listed the Affected devices, Reason for Recall, Risk to Health, and Instructions to Customers. Advised customers to complete and return the "Urgent Medical Device Field Safety Notice (FSN) Response Form" to smithsmedical4390@stericycle.com. All affected devices must be returned to Stericycle for processing. If the product was further distributed, consignees were asked to immediately notify them of the Recall and retrieve all affected devices. For questions contact Stericycle via e-mail at the following address: smithsmedical4390@stericycle.com.

Recalling firm

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

Distribution

Distribution pattern: US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.

Timeline

Recall initiated: 2017-02-09
Terminated: 2018-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.