Z-1458-04

Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size...

Name: Z-1458-04 Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size...
Creator: Premier Dental Products Co
Published: 2004-08-05
License: https://open.fda.gov/license/

Premier Dental Products Co / initiated 2004-08-05 / Terminated

FDA source

Premier Dental Products Co began a recall of Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312... on 2004-08-05. The reason FDA records is "foreign objects (polishing stones) in the tubes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1458-04
Status: Terminated
Initiated: 2004-08-05
Posted: 2004-09-15
Terminated: 2005-11-23
Recalling firm: Premier Dental Products Co
Product: Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item number 1034314 size 4, item number 1034315 size 5, item number 1034316 size 6, item number 1034317 size 7, item number 1034318 size 8, item number 1034319 size 9, and item number 1034320 size 10.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: foreign objects (polishing stones) in the tubes
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 8/5/04 to their distributors. The letter informs the accounts of the problem and the need to return any affected product. The recalling firm issued a second letter dated 8/11/04 to the distributors with instructions to conduct a sub-recall.
Quantity in commerce: 22,324 tubes
Distribution: The products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.
Product codes and lots: all lots ending with S or T

Product code JOH

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)