Device product
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Z-2005-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-2005-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
Code information: Lot Numbers: 13F17A0219 13F17C0013 13F17C0431 13F17D0166 13F17F0070 13F17F0714 13F17G0590 13F17J0392 13F17L0070
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