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

HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow… — recall Z-0331-2017

U.S. FDA — Device Enforcement · United States · 2016-09-02 · Class II

As described by U.S. FDA — Device Enforcement: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external con

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0331-2017
Date of alert
2016-09-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution
Reported risk: Labeling inconsistency
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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