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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics

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  Class 2 Device Recall AngioDynamics see related information
Date Initiated by Firm February 26, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 25, 2006
Recall Number Z-0711-04
Recall Event ID 28419
Product Classification Needle, Aspiration And Injection, Disposable - Product Code GAA
Product AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
Code Information Lot W24005, Use By 2005-03
Recalling Firm/
Manufacturer		 Enpath Medical, Inc.
15301 Highway 55
Plymouth MN 55447-1418
For Additional Information Contact James D. Hartman
763-577-2257
Manufacturer Reason
for Recall		 The product is labeled as sterile product but had not been sterilized.
FDA Determined
Cause 2		 Other
Action The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers.
Quantity in Commerce 20 ten-pack kits
Distribution All of the product was shipped to a distributor in New York.
Total Product Life Cycle TPLC 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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