Z-2003-2018 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

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH

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: 13F17E0712 13F17H0264 13F17K0086 13F17K0547 13F17L0647