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U.S. Department of Health and Human Services

Class 2 Device Recall Pediatric Air Aspirator Needle

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 Class 2 Device Recall Pediatric Air Aspirator Needlesee related information
Date Initiated by FirmNovember 24, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 12, 2004
Recall NumberZ-0281-04
Recall Event ID 27783
510(K)NumberK801393 
Product Classification Needle, Aspiration And Injection, Disposable - Product Code GAA
ProductPediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX
Code Information Part Number, 201015-000, Lot 278862
FEI Number 1625519
Recalling Firm/
Manufacturer		 Novosci Corp
2828 North Cresent Ridge Dr
The Woodlands TX 77381
Manufacturer Reason
for Recall		The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.
FDA Determined
Cause 2		Other
ActionThe firm has contacted the 3 consignees by either phone or email and sent a formal letter to the consignees via FED-EX on 11/24/2003
Quantity in Commerce200 Units
DistributionTX, IL and Germany
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.
510(K) Database510(K)s with Product Code = GAA
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