Arrow International Inc: Medical Device Recall in 2021 - (Recall #: Z-2068-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Product Classification:

Class II

Date Initiated: May 19, 2021

Date Posted: July 21, 2021

Recall Number: Z-2068-2021

Event ID: 88120

Reason for Recall:

Marketed without a 510K

Status: Ongoing

Product Quantity: 48 units

Code Information:

Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082

Distribution Pattern:

US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.

Voluntary or Mandated:

Voluntary: Firm initiated