The Recall Desk

FDA (Devices) recall action 88671

ZOLL Circulation, Inc. recalled 28 products on 2021-10-13

The FDA (Devices) publishes a recall like this one as 28 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 28 pages.

Products
28
Announced
2021-10-13
Critical
0
Units
115,960

Why these products were recalled

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 28

  • ModerateFDA (Devices)··2021-10-13

    ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

    ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

    Product
    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:
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2021-10-13

    ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks

    ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.

    Product
    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.

    Product
    Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Recalled for Potential Leakage

    ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.

    Product
    Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll Cool Line IV Disposable Pack Recalled for Potential Leakage Risk

    ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.

    Product
    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll ICY intravascular heat exchange catheter kit recalled for potential leaks

    ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL COOL LINE Intravascular Catheter Kit recalled for potential tubing leaks

    ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.

    Product
    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
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2021-10-13

    Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks

    ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits distributed worldwide.

    Product
    Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2021-10-13

    Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks

    ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks

    ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.

    Product
    Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll ICY Heparin Disposable Infusion Kits Recalled Due to Potential Leaks

    ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.

    Product
    Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL COOL LINE Intravascular Catheter Kit Recalled for Potential Leaks

    ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.

    Product
    ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2021-10-13

    Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

    ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Labeling Update for Leak Risk

    ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll Quattro IVTM Disposable Pack and Start UP Kit Potential Leak Hazard

    ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.

    Product
    Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll Quattro IV Disposable Packs and Kits Recalled for Potential Leaks

    ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll COOLINE Intravascular Catheter Kit recalled for potential leak hazard

    ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL COOL LINE Catheter Kit recalled for potential tubing leaks

    ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.

    Product
    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
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recall for Potential Leaks

    Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    ZOLL Solex 7 IV Disposable Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

    Product
    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2021-10-13

    Zoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.

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