Class 2 Device Recall John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube

• Date Initiated by Firm: September 14, 2009
• Date Posted: November 09, 2009
• Recall Status: Terminated on December 30, 2010
• Recall Number: Z-0139-2010
• Recall Event ID: 53301
• Product Classification: tracheostomy tube - Product Code BTO
• Product: John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
• Code Information: Codes: Stock Code: 1#4, 3 x 8mm, PO Number: 010707, 011512, 017479, 025991, 027823, 028364 and 029447; Stock Code: 1#5, 3 3/8 x 9mm, PO Number: 010707, 011512, 024048, 025151, 028364, 029447, 031261 and 034276; Stock Code: 1#7, 4 x 11 mm, PO Number: 011512, 020608, 023244, 031261, 033471 and 034276; Stock Code: 1#8, 4 ¿ x 12 mm, PO Number: 011512, 017756, 023244, 027339 and 033252; Stock Code: 1#9, 4 3/8 x 13 mm, PO Number: 011512 and 012479 and Stock Code: 1#10, PO Number: 010707 and 011512.
• FEI Number: 2427360
• Recalling Firm/ Manufacturer: Gf Health Products, Inc.; 2935 Northeast Pkwy; Atlanta GA 30360
• For Additional Information Contact: Shawn Sudia; 678-291-3224
• Manufacturer Reason for Recall: Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.
• FDA Determined Cause: Nonconforming Material/Component
• Action: GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end user names; however it plans to reach end-users by financially supporting a mailing from dealers to their individual customers notifying them of this recall. A follow up 60 day certified mailing will be performed for non-responders. The dealers will receive financial support for this second mailing. A secure third company will be contracted to hold for destruction all products affected by this recall. The method of destruction will be to cut the products into pieces, make them not usable. The FDA will be notified prior to the destruction of product and detailed logs and records will be maintained. Periodic effectiveness status report will be maintained for this recall.
• Quantity in Commerce: 396 units
• Distribution: Nationwide distribution.
• 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.