Recall Z-1459-04 ยท JOH Tube Tracheostomy And Tube Cuff
Premier Dental Products Co
Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00, item number 1034610 size 0, item number 1034611 size 1, item number 1034612 size 2, item number 1034613 size 3, item number 1034614 size 4,item number 1034615 size 5, item number 1034616 size 6, item number 1034617 size 7, item number 1034618 size 8, item number 1034619 size 9, and item number 1034620 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.