Z-0977-2024 Class II Ongoing
FDA device recall Z-0977-2024 was initiated by Maquet Medical Systems USA on January 8, 2024 and is designated Class II. Reason for recall: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following p… The recall status is ongoing. Affected quantity: 1090 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- January 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1090 total
Product Description
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Reason for Recall
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Distribution Pattern
Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
Code Information
UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977