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U.S. Department of Health and Human Services

Class 2 Device Recall Silicone CTS Tracheostomy Tube

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  Class 2 Device Recall Silicone CTS Tracheostomy Tube see related information
Date Initiated by Firm May 08, 2011
Date Posted June 24, 2011
Recall Status1 Terminated 3 on August 30, 2011
Recall Number Z-2657-2011
Recall Event ID 58828
510(K)Number K031553  
Product Classification Tracheostomy tube (w/wo connector) - Product Code BTO
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
Code Information Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080
Recalling Firm/
Manufacturer		 Arcadia Medical Corporation
1140 Millennium Dr
Crown Point IN 46307-7533
Manufacturer 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.
FDA Determined
Cause 2		 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
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
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