Z-0132-2021 Class II Terminated
FDA device recall Z-0132-2021 was initiated by Maquet Cardiovascular Us Sales, Llc on Sep 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… The recall status is terminated (terminated Feb 28, 2023). Affected quantity: 62 units US.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 28, 2020
- Initiation Date
- Sep 24, 2020
- Termination Date
- Feb 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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0132-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026