Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item nu
FDA device recall Z-1466-04 · posted 2004-09-15 · Terminated
Recall details
- Recalling firm
- Premier Dental Products Co
- Reason for recall
- foreign objects (polishing stones) in the tubes
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 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.
- Date initiated
- 2004-08-05
- Date posted
- 2004-09-15
- Date terminated
- 2005-11-23
- Location
- Plymouth Meeting, PA
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