| Class 2 Device Recall AngioVac Circuit Pack | |
Date Initiated by Firm | March 21, 2016 |
Date Posted | May 20, 2016 |
Recall Status1 |
Terminated 3 on September 18, 2017 |
Recall Number | Z-1702-2016 |
Recall Event ID |
73815 |
510(K)Number | K142607 |
Product Classification |
Tubing, pump, cardiopulmonary bypass - Product Code DWE
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Product | AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, 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: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714. |
Recalling Firm/ Manufacturer |
Angiodynamics Inc. (Navilyst Medical Inc.) 10 Glens Falls Tech Park Glens Falls NY 12801-3864
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For Additional Information Contact | Gary 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 |
Action | On 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 Commerce | Domestic: 377 kits |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = DWE
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