Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1334-2018)

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:

Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

Product Classification:

Class II

Date Initiated: December 22, 2017

Date Posted: April 18, 2018

Recall Number: Z-1334-2018

Event ID: 79512

Reason for Recall:

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Status: Terminated

Product Quantity:

Code Information:

Lot Numbers: (1) 13F17D0188, 13F17E0570; (2) 13F17E0660

Distribution Pattern:

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated