Recall Z-1469-04 ยท JOH Tube Tracheostomy And Tube Cuff
Premier Dental Products Co
Laryngectomy Tubes, Jackson Improved Stainless Steel, item number1037414 size 4, item number 1037415 size 5, item number 1037416 size 6, item number 1037417 size 7, item number 1037418 size 8, item number 1037419 size 9, and item number 1037420 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.