Device product

Maximal Barrier Drape; Product Codes: ASK-00001-1A

Z-1963-2018

April 11, 2018

Class II

Product summary

Firm: Arrow International Inc
Event: Event 79890
Status: Terminated
Classification: Class II
Quantity: 416,055 total products
Official record key: device-enforcement:Z-1963-2018

Official wording

Reason: Product sterility may be compromised due to unsealed packaging.

Code information: Lot Numbers: 13F17E0104 13F17F0318 13F17G0569 13F17J0423 13F17L0130

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
reason.labeling_packaging · v1.0.0

unsealed packaging
Sterility assurance
reason.sterility_assurance · v1.0.0

sterility may be compromised