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Terminated

Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 1037215 size 5, item number 1037216 size 6, item number 1037217 size 7, item number 1037218 size 8, item number 1037219 size 9, and item number 1037220 size 10.

FDA Recall Z-1468-04 · 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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