Recall Z-1702-2016— Angiodynamics Inc. (Navilyst Medical Inc.)
Class II · Terminated
Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2016-03-21, terminated 2017-09-18. It names one FDA 510(k) clearance: K142607. 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.. 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..
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-21
- Terminated
- 2017-09-18
- Firm location
- Glens Falls, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.