Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2016 - (Recall #: Z-1702-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 21, 2016

Date Posted: June 1, 2016

Recall Number: Z-1702-2016

Event ID: 73815

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.

Status: Terminated

Product Quantity: Domestic: 377 kits

Code Information:

Lot Numbers: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated