Arrow International Inc recalls HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contami

Recalled November 9, 2016 · FDA recall Z-0331-2017 · Arrow International

Hazard

Labeling inconsistency · FDA Class II

Units

330 units in US and 1,031 units OUS

Sold at

Nationwide distribution

Description

Labeling inconsistency

Product

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 contamination.

Manufacturer(s)

Arrow International Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →