Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1331-2018)

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:

(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP

Product Classification:

Class II

Date Initiated: December 22, 2017

Date Posted: April 18, 2018

Recall Number: Z-1331-2018

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) 13F17D0048; (2) 13F17E0659; (3) 13F17A0075, 13F17C0503, 13F17D0296, 13F17E0541, 13F17F0220, 13F17G0002

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