Z-1959-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
April 11, 2018
Termination Date
May 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
416,055 total products

Product Description

Echogenic Introducer Needle; Product Code: AN-04318

Reason for Recall

Product sterility may be compromised due to unsealed packaging.

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

Code Information

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