Device product
Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
Z-1960-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-1960-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
Code information: Lot Numbers: Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445
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