Z-1972-2018 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

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM

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: 13F17C0179 13F17E0655 13F17G0301 13F17H0284 13F17K0566 13F17M0019