Z-0132-2021 Class II Terminated
FDA device recall Z-0132-2021 was initiated by Maquet Cardiovascular Us Sales, Llc on September 24, 2020 and is designated Class II. Reason for recall: Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source)… The recall status is terminated (terminated February 28, 2023). Affected quantity: 62 units US.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- February 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units US
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, MACAU, MACEDONIA, MALAYSIA, MEXICO, NEW ZEALAND, OMAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNESIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.