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U.S. Department of Health and Human Services

Class 2 Device Recall Tracheostomy tubes

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  Class 2 Device Recall Tracheostomy tubes see related information
Date Initiated by Firm April 18, 2012
Date Posted May 21, 2012
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-1628-2012
Recall Event ID 61663
510(K)Number K031553  
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
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.
Code Information Lot numbers: 01103307 (50 units) and 01107055 (73 units)
Recalling Firm/
Arcadia Medical Corporation
1140 Millennium Dr
Crown Point IN 46307-7533
For Additional Information Contact Trena Depel
Manufacturer 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.
FDA Determined
Cause 2
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, trena@arcadiamedical.com. 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.
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 = BTO and Original Applicant = ARCADIA MEDICAL CORPORATION