FDAFDA · Food and drugs·Recall number Z-2021-2018
Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
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: Product Code: PL-05041 13F17G0050 13F17J0360 13F17K0376 Product Code and PL-05052: 13F17C0435 13F17E0720 13F17G0077 13F17G0514
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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