Z-1146-2023 Class I Ongoing
FDA device recall Z-1146-2023 was initiated by Datascope Corp. on February 7, 2023 and is designated Class I. Reason for recall: An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communicatio… The recall status is ongoing. Affected quantity: 4062 Total.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4062 Total
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, TURKMENISTAN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, AND YEMEN.