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U.S. Department of Health and Human Services

Class 2 Device Recall Air Lon Nylon Tracheostomy Tubes

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 Class 2 Device Recall Air Lon Nylon Tracheostomy Tubessee related information
Date Initiated by FirmAugust 05, 2004
Date PostedSeptember 15, 2004
Recall Status1 Terminated 3 on November 23, 2005
Recall NumberZ-1465-04
Recall Event ID 29920
Product Classification Tube Tracheostomy And Tube Cuff - Product Code JOH
ProductTracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size 4, item number 1050154 size 5, item number 1050156 size 6, item number 1050158 size 7, and item number 1050160 size 8.
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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