Haemonetics recalls CS Elite Fastpack 125mL autotransfusion devices with potential leaks causing fluid trapping and device errors. Affected units have bowl cracks or missing crack-check instructions from Oct 2014 to Oct 2019.
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.
Haemonetics is recalling CS Elite Fastpack 125mL autotransfusion devices that may leak fluid due to cracks in the bowl. This could cause the device to show error messages and potentially leave blood trapped inside.
Cracks in the bowl can trap fluid inside, causing the device to display error messages. This may lead to incomplete blood washing and potential blood residue in the patient.
Medical professionals using the device during surgeries or trauma treatments. Patients receiving blood transfusions through this equipment are most at risk.
Check for cracks in the bowl. Products distributed between October 2014 and October 2019 with lot numbers 1902003HTT, 1902002HTT, or 1909003HTT are affected.
Inspect the bowl for cracks; if present, stop using the device immediately.
The device may develop leaks due to bowl cracks, causing fluid to trap inside and show error messages.
Check for bowl cracks; if present, stop using it immediately. The device was distributed between October 2014 and October 2019.
Yes, lot numbers 1902003HTT, 1902002HTT, and 1909003HTT are affected.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0896-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0896-2020 from Haemonetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.