FDA Device

Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item number 1034314 size 4, item number 1034315 size 5, item number 1034316 size 6, item number 1034317 size 7, item number 1034318 size 8, item number 1034319 size 9, and item number 1034320 size 10.

Hazard

foreign objects (polishing stones) in the tubes

What You Should Do

Remedy

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.

Products

Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item
Brand
Premier Dental Products Co
UPC
all lots ending with S or T

Units Affected

22,324 tubes