ZOLL Circulation, Inc.: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Agency Publication Date: October 6, 2021

Affected Products

Product: Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

All Lots

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

All Lots

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

All Lots

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

All Lots

Product: 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

All Lots

Product: Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

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

All Lots

Product: Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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:

All Lots

Product: ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88671

Status: Resolved

Manufacturer: ZOLL Circulation, Inc.

Manufactured In: United States

Units Affected: 28 products (17,869 Kits; 1,253 Kits; 4,812 kits; 5,524 Kits; 5, 345 KIts; 11 UNITS; 6,395 units; 333 units; 33,066 units; 20,475 units; 13,935 units; 1,256 units; 188 units; 98 units; 1,733 units; 2,833 units; 3,425 units; 3 units; 58 kits; 16 bundles; 55 bundles; 42 bundles; 334 bundles; 79 bundles; 144 bundles; 1,122 bundled kits; 579 bundled kits; 322 BUNDLE KITS)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Product: Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

All Lots

Product: Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

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

All Lots

Product: Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

All Lots

Product: Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

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

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88671

Status: Resolved

Manufacturer: ZOLL Circulation, Inc.

Manufactured In: United States