Class 2 Device Recall Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes

• Date Initiated by Firm: May 26, 2020
• Create Date: July 01, 2020
• Recall Status: Terminated on May 05, 2021
• Recall Number: Z-2485-2020
• Recall Event ID: 85730
• 510(K)Number: K081440
• Product Classification: Tube tracheostomy and tube cuff - Product Code JOH
• Product: Pediatric Adjustable Flange Tracheostomy Tube Cuffless
• Code Information: Model Number: 60HA30, Lot: 3794165, SKU 60HA30
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: 763-383-3072
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 20 devices
• Distribution: U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JOH and Original Applicant = SMITHS MEDICAL ASD, INC.