BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Recall
- Recall Number
- Z-0977-2024
- Event Number
- 93852
- Firm
- Maquet Medical Systems USA
- FEI Number
- 3008355164
- Product Code
- KFM
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- January 8, 2024
- Posted
- February 2, 2024
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
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.
On January 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letters. Customers were instructed to remove all affected RF-32 pumps from use. If product is already in use, the firm advised to not discontinue therapy, but to monitor the patient closely for signs of infection. Customers should quarantine all affected product and return unopened/unexpired affected product to MCP/Getinge. Please contact MCP/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) number and shipping instructions. Distributors should forward the recall document to customers who received affected products. Information also posted on firm's website: https://www.getinge.com/us/products-and-solutions/cardiovascular-procedures/ ***Updated 3/21/24*** Firm expanded field action to include additional lots. Amended notifications were sent to affected US customers on March 20, 2024.
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.
1090 total