Recall Z-1470-04 ยท JOH Tube Tracheostomy And Tube Cuff
Premier Dental Products Co
Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10.
| 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.