—#181651

Product

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K081440
Affected lot / code info: Model Number: 60HA30, Lot: 3794165, SKU 60HA30

Why it was recalled

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

Root cause (FDA determination)

Process control

Action the firm took

Smiths Medical sent a customer notification letter dated 05/18/2020, titled "Urgent Medical Device Recall Notice", to customers. The Recall Notice states that Smiths Medical has initiated a voluntary Medical Device Recall for one lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes (SKU 60HA30) that was packaged with a 3.5mm ID adjustable neck flange. The notice instructs customers to locate and quarantine the affected 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes by referring customers to the attached Urgent Medical Device Recall Response Form. Customers should determine the number of affected devices in their possession and complete the attached Urgent Medical Device Recall Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form should be returned even if customers do not have any affected product in their possession. Product credit (and/or replacement) will be processed once the Urgent Medical Device Field Recall Response Form is received. All affected product must be returned to Smiths Medical Compliance. Pre-paid shipping labels are included with the notice. A copy of the completed Response Form should be inside each box to facilitate processing. Boxes should be sealed and labeled with the facility name prior to shipping to Smiths Medical. If distributors have potentially distributed affected devices to customers, they should immediately notify them of the Urgent Medical Device Recall by forwarding them a copy of the Recall Notice. All communication to Smiths Medical must be completed by the distributor. End users should not respond directly or return devices to Smiths Medical. Questions regarding the notification, should contact Smiths Medical via email at fieldactions@smiths-medical.com. The response forms should be completed and returned to fieldactions@smiths-medical.com within 10 days of receipt.

Recalling firm

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

Distribution

Distribution pattern: U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.

Timeline

Recall initiated: 2020-05-26
Terminated: 2021-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181651. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.