Recall Z-0978-2024— Maquet Medical Systems USA
Class II · Ongoing
Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2024-01-08. It names one FDA 510(k) clearance: K090515. Product: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.. Reason: 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..
- Recalling firm
- Maquet Medical Systems USA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-08
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.