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Recall Observatory FDA recall evidence

Device 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.

Z-1702-2016

March 21, 2016

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 73815
Status
Terminated
Classification
Class II
Quantity
Domestic: 377 kits
Official record key
device-enforcement:Z-1702-2016

Official wording

Reason: 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.

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

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.