Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-3197-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

Product Classification:

Class II

Date Initiated: July 30, 2018

Date Posted: September 26, 2018

Recall Number: Z-3197-2018

Event ID: 80872

Reason for Recall:

Products are labeled with an incorrect expiration date

Status: Terminated

Product Quantity: 7 eaches

Code Information:

Lot/Batch Number:16F18A0010 Use By: 2023-12-31

Distribution Pattern:

US in the state of PA

Voluntary or Mandated:

Voluntary: Firm initiated