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

Recall Z-0590-2020 — CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

U.S. FDA — Device Enforcement · United States · 2019-11-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0590-2020
Date of alert
2019-11-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00827002515772
Reported risk: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
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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