Z-2485-2020Class II

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Name: Z-2485-2020 Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Creator: Smiths Medical ASD Inc.
Published: 2020-05-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-05-26 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Pediatric Adjustable Flange Tracheostomy Tube Cuffless on 2020-05-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2485-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-26
Posted: 2020-07-01
Terminated: 2021-05-05
Recalling firm: Abbott Medical
Product: Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Product code: JOH Tube Tracheostomy And Tube Cuff
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.
Root cause tag: manufacturing process
FDA root 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 [email protected]. 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 [email protected]. The response forms should be completed and returned to [email protected] 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.
Product codes and lots: Model Number: 60HA30, Lot: 3794165, SKU 60HA30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2485-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-07-01

Product code JOH

K081440Class IIBivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy TubesSmiths Medical Asd, Inc. / cleared 2008-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)