Z-1987-2018 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 Codes: ASK-42703-MHW and ASK-42703-OLL1

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: Product Codes ASK-42703-MHW: 13F16M0282 13F17D0183 13F17H0260 13F17M0344 Product Code ASK-42703-OLL1: 13F17C0293 13F17E0414 13F17J0243