FDA Medical Device Recalls (openFDA)
Premier Dental Products Co: 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.
- Recall number
- Z-1458-04
- 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.
- Status
- Terminated
- Initiated
- 2004-08-05
- Posted
- 2004-09-15
- Terminated
- 2005-11-23
- Reason
- foreign objects (polishing stones) in the tubes
- 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
- 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.
- Lot, serial or model codes
- all lots ending with S or T
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 2511556
- Firm city
- Plymouth Meeting
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28