Z-1989-2018 Class II Terminated
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
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
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 code CDC-42854-P1A: 13F17C0137 13F17E0177 13F17E0598 13F17F0644 13F17G0287 13F17H0118 13F17K0156 13F17L0017 13F17M0158 Product code CDC-45854-P1A: 13F17C0396 13F17C0439 13F17D0062 13F17D0284 13F17E0618 13F17F0126 13F17G0293 13F17H0263 13F17J0055 13F17K0168 13F17L0021 13F17L0353 13F17L0590