Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1991-2018)

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:

Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-1991-2018

Event ID: 79890

Reason for Recall:

Product sterility may be compromised due to unsealed packaging.

Status: Terminated

Product Quantity: 416,055 total products

Code Information:

Lot Numbers: Product Code ASK-45854-PSFM: 13F17C0072 13F17E0166 13F17H0261 13F17J0339 13F17L0020 13F17L0401 Product Code ASK-42854-PRR: 13F17B0034 13F17B0278 13F17E0800 13F17H0142 13F17K0160

Distribution Pattern:

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

Voluntary or Mandated:

Voluntary: Firm initiated