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

Recall Z-0050-2022 — 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

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-0050-2022
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
Barcode (EAN/GTIN)
00849111075527
Reported risk: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.