Tracheostomy Tubes, Jackson Improved Stainless Steel, item number 1034900 size 00, item number 1034910 size 0, item number 1034911 size 1, item number 1034912 size 2, item number 1034913 size 3, item number 1034914 size 4, item number 1034915 size 5, item number 1034916 size 6, item number 1034917 size 7, item number 1034918 size 8, item number 1034919 size 9, and item number 1034920 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-1460-04
- 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