Device product
Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
Z-2029-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-2029-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
Code information: Lot Numbers: 13F17B0051 13F17E0713 13F17F0767 13F17J0010
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