Z-0139-2010

John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube

Name: Z-0139-2010 John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube
Creator: Gf Health Products, Inc.
Published: 2009-09-14
License: https://open.fda.gov/license/

GF Health Products, Inc. / initiated 2009-09-14 / Terminated / root cause: manufacturing process

FDA source

Gf Health Products, Inc. began a recall of John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube on 2009-09-14. The reason FDA records is "Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications". 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-0139-2010
Status: Terminated
Initiated: 2009-09-14
Posted: 2009-11-09
Terminated: 2010-12-30
Recalling firm: GF Health Products, Inc.
Product: John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Codes: Stock Code: 1#4, 3x 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.

Product code BTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)