Z-1628-2012

Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size...

Name: Z-1628-2012 Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size...
Creator: Arcadia Medical Corporation
Published: 2012-04-18
License: https://open.fda.gov/license/

Arcadia Medical Corporation / initiated 2012-04-18 / Terminated / root cause: manufacturing process

FDA source

Arcadia Medical Corporation began a recall of Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use... on 2012-04-18. The reason FDA records is "A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula". 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-1628-2012
Status: Terminated
Initiated: 2012-04-18
Posted: 2012-05-21
Terminated: 2012-08-13
Recalling firm: Arcadia Medical Corporation
Product: Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, [email protected]. Phone: 925-918-0595 Fax: (415) 762-5489
Quantity in commerce: 01103307 (50 units) and 01107055 (73 units)
Distribution: Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
Product codes and lots: Lot numbers: 01103307 (50 units) and 01107055 (73 units)

Product code BTO

K031553Class IISilicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy TubesArcadia Medical Corporation / cleared 2003-11-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)