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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics EmboSafe

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 Class 2 Device Recall AngioDynamics EmboSafesee related information
Date Initiated by FirmJune 06, 2003
Date PostedJuly 02, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall NumberZ-0964-03
Recall Event ID 26475
510(K)NumberK021044 
Product Classification Introducer, Catheter - Product Code DYB
ProductAngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601
Code Information Lot Numbers W24305, W24310, and W24311
Recalling Firm/
Manufacturer		 MedAmicus,Inc
15301 Highway 55 West
Plymouth MN 55447
For Additional Information ContactKaryl Haskell
763-577-2257
Manufacturer Reason
for Recall		Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
FDA Determined
Cause 2		Other
ActionThe consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
Quantity in Commerce955 boxes
DistributionThe products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
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 = DYB
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