Device product
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Z-1989-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-1989-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
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
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
Derived failure modes
-
Labeling or packaging
unsealed packaging
-
Sterility assurance
sterility may be compromised