Z-2657-2011

Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia...

Name: Z-2657-2011 Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia...
Creator: Arcadia Medical Corporation
Published: 2011-05-08
License: https://open.fda.gov/license/

Arcadia Medical Corporation / initiated 2011-05-08 / Terminated / root cause: manufacturing process

FDA source

Arcadia Medical Corporation began a recall of Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube... on 2011-05-08. The reason FDA records is "The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability...". 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-2657-2011
Status: Terminated
Initiated: 2011-05-08
Posted: 2011-06-24
Terminated: 2011-08-30
Recalling firm: Arcadia Medical Corporation
Product: Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management Arcadia Medical Corporation 1450 East American Lane, Schaumburg, IL 60173 USA Arcadia Medical Corporation Tortola, British Virgin Islands www.arcadiamedical.com, Made in USA
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arcadia Medical Corporation sent a "MEDICAL DEVICE RECALL" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.
Quantity in commerce: 118
Distribution: Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania
Product codes and lots: Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080

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)