Recall Z-1466-04 ยท JOH Tube Tracheostomy And Tube Cuff
Premier Dental Products Co
Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, item number 1050188 size 7, and item number 1050190 size 8.
| Date | Sep 15, 2004 (initiated Aug 5, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.