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U.S. Department of Health and Human Services

Class 2 Device Recall AngioVac Circuit

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 Class 2 Device Recall AngioVac Circuitsee related information
Date Initiated by FirmMarch 21, 2016
Date PostedMay 20, 2016
Recall Status1 Terminated 3 on September 18, 2017
Recall NumberZ-1701-2016
Recall Event ID 73815
510(K)NumberK092486 
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
ProductVortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Code Information Lot Numbers 37FE2901, 37GD2908, 37KD2405 
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information ContactGary Barrett
508-658-7940
Manufacturer Reason
for Recall		Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
FDA Determined
Cause 2		Environmental control
ActionOn 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.
Quantity in CommerceDomestic: 339 kits
DistributionNationwide Distribution.
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 = DWE
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