FDAFDA · Food and drugs·Recall number Z-2026-2018
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
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: 13F17A0120 13F17A0287 13F17C0018 13F17D0136 13F17E0122
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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