Product Wiki · Recalls · U.S. FDA — Device Enforcement

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: — recall Z-0042-2022

U.S. FDA — Device Enforcement · United States · 2021-08-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0042-2022
Date of alert
2021-08-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ZOLL Circulation, Inc.
Product category
device
Product type
Devices
Reported risk: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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