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Update as of September 13, 2013:
Access additional details regarding Whole Blood Collection Sets unaffected by the potential for a leak to occur in the Flexible Y Connector of the donor line (the “Unaffected Products”) View document
On Thursday, December 6, 2012, Haemonetics issued a Field Action Letter, with concurrence of the U.S. FDA to affected customers in the U.S. Communications with other relevant regulatory agencies outside the United States regarding this letter are in process. The field action requests pre- and post- phlebotomy visual inspection of a component in certain whole blood collection sets.
An assessment completed by Haemonetics indicates that health risk is minimal and there have been no reports of adverse events to date. Affected customers are receiving product and continuing blood collection activities. There is potential for a leak to occur at a very low frequency in the component, a vendor supplied flexible Y connector in the donor line. Haemonetics has no higher priority than working with its customers to ensure the safety of blood products and patients.
Read Field Action letter
Additionally, we have prepared a video demonstrating the actions in the letter for added clarity to our field personnel and customer personnel. Please contact your immediate supervisor with any questions and, as always, know that Haemonetics has no higher priority than working with its customers to ensure the safety of blood products and patients.
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