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U.S. Department of Health and Human Services

Class 2 Device Recall Jackson Original Stainless Steel Tracheostomy Tubes

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 Class 2 Device Recall Jackson Original Stainless Steel Tracheostomy Tubessee related information
Date Initiated by FirmAugust 05, 2004
Date PostedSeptember 15, 2004
Recall Status1 Terminated 3 on November 23, 2005
Recall NumberZ-1458-04
Recall Event ID 29920
Product Classification Tube Tracheostomy And Tube Cuff - Product Code JOH
ProductTracheostomy 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.
Code Information all lots ending with S or T
Recalling Firm/
Manufacturer		 Premier Dental Products Co
1710 Romano Dr
Plymouth Meeting PA 19462-2822
For Additional Information ContactVince D'Alessandro
610-239-6015
Manufacturer Reason
for Recall		foreign objects (polishing stones) in the tubes
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce22,324 tubes
DistributionThe products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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