The lots are being recalled due to failures of the blood circuit associated with too many mismatch alarms. The blood circuits may indicate "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion.

As of the date of this Current Report on Form 8-K, the Company is aware of five reported incidences of blood circuit product failures, with three leading to patient dehydration and requiring administration of fluids.

The recall is being conducted with the knowledge of the U.S. Food and Drug Administration which has not yet characterized the Class of the recall.