Device product
Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
Z-2011-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-2011-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
Code information: Lot Numbers: 13F17B0039 13F17C0181 13F17D0226 13F17E0065 13F17E0724 13F17F0651 13F17G0531 13F17H0377 13F17J0273 13F17L0216 13F17L0218
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