Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1959-2018)

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:

Echogenic Introducer Needle; Product Code: AN-04318

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-1959-2018

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: 13F17A0231 13F17B0321 13F17C0241 13F17D0233 13F17E0301 13F17E0725 13F17F0603 13F17G0193 13F17J0089 13F17K0232 13F17L0230 13F17L0231 13F17L0232 13F17L0233

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