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U.S. Department of Health and Human Services

Class 2 Device Recall SoftVu Omni Flush Angiographic Catheter

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 Class 2 Device Recall SoftVu Omni Flush Angiographic Cathetersee related information
Date Initiated by FirmSeptember 22, 2017
Date PostedFebruary 13, 2018
Recall Status1 Terminated 3 on September 19, 2018
Recall NumberZ-0742-2018
Recall Event ID 79193
510(K)NumberK112452 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductSoft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Code Information Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactDavid Greer
518-795-1676
Manufacturer Reason
for Recall		Product was placed into distribution prior to completion of all required post sterilization release activities.
FDA Determined
Cause 2		Process control
ActionConsignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676.
Quantity in Commerce28
DistributionUS Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
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 = DQO
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