Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1330-2018)

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) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

Product Classification:

Class II

Date Initiated: December 22, 2017

Date Posted: April 18, 2018

Recall Number: Z-1330-2018

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) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827

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