Haemonetics Corporation JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Recommended Action

Per FDA guidance

On October 21 & 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: SAFETY NOTIFICATION FOR 125ml and 225ml Centrifuge Bowls Attention: Risk Management Director, Materials Manager and Director Biomedical Engineering Please forward this communication to all potential users of the products. Dear Customer, Haemonetics makes continuous efforts to supply our customers with products that meet the highest levels of product quality and reliability. We have recently identified a potential issue with Cell Saver 5/5+ and Cell Saver Elite/Elite + 125ml and 225ml bowl sets. The investigation has determined that a small number of bowl sets may have the potential to develop leaks at the inner core, which could result in fluid becoming trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. Note: The likelihood of experiencing an inner core leak is low, and no fluid has been found to exit the bowl into the Cell Saver device. We have a dedicated team implementing corrective actions to resolve this issue. What to do if experiencing Long Empty error code on your device: If an error code indicates Long Empty, complete the troubleshooting guidance provided on Page 3 in this communication. If the error message continues, the user should remove the bowl, tilt it upside down and visually check the base for cracks directly on or extending from the ribs. See Page 4 for photo example of where to inspect: -If no cracks are observed and procedure is complete, proceed with using the blood in the reinfusion bag. No further action is required. If continuing with the procedure, use a new processing set. - If cracks are confirmed, the user should assume incomplete washing of the bowl contents, and the wash cycle should be repeated on blood that is in the reinfusion bag. Take any residual RBCs in the reinfusion bag, and empty its contents into the cardiotomy reservoir to rep