Important Product Information Regarding the Haemonetics Leukotrap RC System with RC2D Filter
To: Blood Collection Establishments, Blood Transfusion Services Laboratory Services Supervisors, and Health Care Providers
The purpose of this notification is to inform you of important information regarding the Haemonetics Leukotrap RC System with RC2D filter.
Summary of the Issue
FDA is informing blood establishments and the healthcare community that Haemonetics reported that use of its Leukotrap RC System with RC2D filter sets distributed to final users since April 14, 2016, has been associated with higher than acceptable residual leukocyte counts in a variable number of units prepared with this filter set. The firm is now voluntarily recalling all lots of the product distributed since April 14, 2016.
This filter failure may result in red blood cell units that are not adequately leukocyte reduced and may pose a health problem for some patients who are transfused with affected red blood cells. Awareness and understanding of this issue is important for blood collection establishments that have performed leukocyte reduction using the affected lots of Haemonetics Leukotrap RC System with RC2D filter and transfusion services that may have received red blood cell units prepared with an affected Haemonetics Leukotrap RC System with RC2D filter set.
Information for Blood Collection Establishments
Known or potentially affected blood products should not be re-filtered because of potential damage to red blood cells. Blood collection establishments may perform counting of residual leukocytes after filtration with filters sets from affected lots to enable labeling of individual units of red blood cells as leukocyte reduced. Tests for counting residual leukocytes are normally performed within 48 hours of leukocyte reduction. Alternative procedures for delayed counting of residual leukocytes should be discussed with FDA. Blood collection establishments with questions should contact their Consumer Safety Officer or CBER’s Office of Communication, Outreach and Development at (800) 835-4709 or Industry.Biologics@fda.hhs.gov. For red blood cell units already distributed, blood collection establishments should notify their consignees.
Information for Health Care Providers
Health care providers should be aware that red blood cell units collected using an affected Haemonetics Leukotrap RC System with RC2D filter may not have been adequately leukocyte reduced. If necessary, you should contact your Transfusion Service to determine whether units issued for transfusion were confirmed to be leukocyte reduced. In situations where leukocyte reduced red blood cells are unavailable for all patients, it may be prudent to triage the use of suitably tested units to patients at highest risk of adverse events from exposure to leukocytes.
Reporting Adverse Events
Health care providers are encouraged to report adverse events that have occurred in patients who received blood products manufactured using the Haemonetics Leukotrap RC System with RC2D filter. You are encouraged to report adverse events to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.