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/ Manufacturer |
Arcadia Medical Corporation 1140 Millennium Dr Crown Point IN 46307-7533
|
For Additional Information Contact | Trena Depel 925-918-0595 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = BTO
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