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Terminated

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.

FDA Recall Z-1458-04 · 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.

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