ZOLL Circulation, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 6

Known Identifiers & Locations

FEI Numbers 3003793491
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (6)

Recall # Product Description Initiation Date Status Action
Z-0039-2022 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 Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details
Z-0040-2022 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 Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details
Z-0041-2022 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 Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details
Z-0042-2022 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: Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details
Z-0043-2022 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 Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details
Z-0044-2022 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 Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing 2021-08-06 Terminated View Details

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