Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1323-2018)

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) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

Product Classification:

Class II

Date Initiated: December 22, 2017

Date Posted: April 18, 2018

Recall Number: Z-1323-2018

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:

(1) Lot Number: 13F17D0179; (2) Lot Numbers: 13F17B0232, 13F17C0357, 13F17D0312, 13F17E0289, 13F17F0154, 13F17F0327, 13F17F0614

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