FDA Medical Device Recalls (openFDA)
Premier Dental Products Co: Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00, item number 1034610 size 0, item number 1034611 size 1, item number 1034612 size 2, item number 1034613 size 3, item number 1034614 size 4,item number 1034615 size 5, item number 1034616 size 6, item number 1034617 size 7, item number 1034618 size 8, item number 1034619 size 9, and item number 1034620 size 10.
- Recall number
- Z-1459-04
- Recalling firm
- Premier Dental Products Co
- Product
- Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00, item number 1034610 size 0, item number 1034611 size 1, item number 1034612 size 2, item number 1034613 size 3, item number 1034614 size 4,item number 1034615 size 5, item number 1034616 size 6, item number 1034617 size 7, item number 1034618 size 8, item number 1034619 size 9, and item number 1034620 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