Arrow International Inc: Medical Device Recall in 2017 - (Recall #: Z-2329-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

Product Classification:

Class II

Date Initiated: May 9, 2017

Date Posted: June 21, 2017

Recall Number: Z-2329-2017

Event ID: 77232

Reason for Recall:

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Status: Terminated

Product Quantity: 27,485 units distributed in U.S, 4,371 units distributed internationally

Code Information:

Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Canada

Voluntary or Mandated:

Voluntary: Firm initiated