Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Japan CS Elite FASTPACK DISP. SET - 125ML - Product Recalled by Haemonetics Corporation Due to Potential to develop leaks at the inner core...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Haemonetics Corporation directly.
Affected Products
Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.
Quantity: 14278
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Haemonetics Corporation
Haemonetics Corporation has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report