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

Recall date

September 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0331-2017

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Nationwide distribution

Why it was recalled

Labeling inconsistency

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.