Recall Z-0331-2017— Arrow International Inc

Name: FDA recall Z-0331-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2016-09-02, terminated 2020-02-20. It names one FDA 510(k) clearance: K895268. 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.. Reason: Labeling inconsistency.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-02
Terminated: 2020-02-20
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K895268 — ARROW HANDS-OFF THERMO-PACEArrow Intl., Inc.·cleared 1989-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Labeling inconsistency

Data sourced from openFDA. This site is unofficial and independent of the FDA.