ZOLL Circulation, Inc.

Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

FDA Recall

Terminated ·Zoll Circulation, Inc.·Product code DRM·January 28, 2008

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

FDA Recall

Terminated ·Zoll Circulation, Inc.·Product code DRM·August 8, 2012

Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

FDA Recall

Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022

Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

FDA Recall

Terminated ·Zoll Circulation, Inc.·Product code DRM·July 16, 2013

Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code PAV·April 1, 2014

Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

FDA Recall

Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021