Device product
Maximal Barrier Drape; Product Codes: ASK-00002-1A
Z-1964-2018
Product summary
- Event
- Event 79890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416,055 total products
- Official record key
device-enforcement:Z-1964-2018
Official wording
Reason: Product sterility may be compromised due to unsealed packaging.
Code information: Lot Numbers: 13F17A0212 13F17D0025 13F17D0154 13F17E0193 13F17F0352 13F17G0102 13F17G0102 13F17G0347 13F17H0347 13F17K0324 13F17K0377 13F17L0462
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