FDA Medical Device Recalls (openFDA)
Premier Dental Products Co: Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 size 10.
- Recall number
- Z-1471-04
- Recalling firm
- Premier Dental Products Co
- Product
- Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 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