FDAFDA · Food and drugs·Recall number Z-1968-2018
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Published June 6, 2018 · Recall initiated: April 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product sterility may be compromised due to unsealed packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- 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
- Lot
- Lot Numbers: 13F17A0195 13F17D0213 13F17F0428 13F17K0314 13F17L0113
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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