BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
- Company
- Maquet Medical Systems, Usa
- Recall Initiated
- January 8, 2024
- Posted
- February 2, 2024
- Recall Number
- Z-0978-2024
- Quantity
- 1090 total
- Firm Location
- Wayne, NJ
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
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.
Lot / Code Info
UDI-DI 4037691650326 Lots 3000283239 and 3000330438 ***Lots added 3/21/24*** 3000334430; 3000344495; 3000351245
Root Cause
Process control
Action Taken
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.