Recall Z-1462-04 ยท JOH Tube Tracheostomy And Tube Cuff
Premier Dental Products Co
Tracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00, item number 1034940 size 0, item number 1034941 size 1, item number 1034942 size 2, item number 1034943 size 3, item number 1034944 size 4, item number 1034945 size 5, item number 1034946 size 6, item number 1034947 size 7, item number 1034948 size 8, item number 1034949 size 9, and item number 1034950 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.