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.
This recall has been terminated (originally issued September 15, 2004).
- Company
- Premier Dental Products Co
- Recall Initiated
- August 5, 2004
- Posted
- September 15, 2004
- Terminated
- November 23, 2005
- Recall Number
- Z-1458-04
- Quantity
- 22,324 tubes
- Firm Location
- Plymouth Meeting, PA
- Official Source
- View on FDA website ↗
Reason for Recall
foreign objects (polishing stones) in the 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 / Code Info
all lots ending with S or T
Root Cause
Other
Action Taken
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.
More recalls by Premier Dental Products Co
Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
Nov 20, 2004
Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
Nov 20, 2004