Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 size 6, item number 1034927 size 7, item number 1034928 size 8, item number 8100468 size 9, and item number 8100234 size 10.
FDA Recall Z-1461-04 · Posted 2004-09-15
Recalling FirmPremier Dental Products Co
Recall StatusTerminated
Product CodeJOH
Date Initiated2004-08-05
Date Terminated2005-11-23
Product Quantity22,324 tubes
Reason for Recall
foreign objects (polishing stones) in the tubes
Firm 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.
Root Cause
Other
Distribution Pattern
The products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.