Arrow International Inc: Medical Device Recall in 2016 - (Recall #: Z-0331-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 2, 2016

Date Posted: November 9, 2016

Recall Number: Z-0331-2017

Event ID: 75372

Reason for Recall:

Labeling inconsistency

Status: Terminated

Product Quantity: 330 units in US and 1,031 units OUS

Code Information:

Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated