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U.S. Department of Health and Human Services

Class 2 Device Recall Jackson Improved Short Stainless Steel Tracheostomy Tubes

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 Class 2 Device Recall Jackson Improved Short 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-1462-04
Recall Event ID 29920
Product Classification Tube Tracheostomy And Tube Cuff - Product Code JOH
ProductTracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00, item number 1034940 size 0, item number 1034941 size 1, item number 1034942 size 2, item number 1034943 size 3, item number 1034944 size 4, item number 1034945 size 5, item number 1034946 size 6, item number 1034947 size 7, item number 1034948 size 8, item number 1034949 size 9, and item number 1034950 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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