Haemonetics recalls CS Elite Fastpack 225mL 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 225mL autotransfusion devices that may leak fluid, causing errors and incomplete washing. This could lead to improper blood processing during medical procedures.
The device may develop leaks at the inner core, trapping fluid inside the bowl. This can cause the device to display an error message indicating incomplete washing, potentially leading to improper blood processing.
Medical professionals using the device during surgeries or trauma treatments are most at risk. Patients receiving blood transfusions through this device could be affected if the leak causes incomplete washing.
Check for bowl cracks in the device. Affected units were manufactured between October 2014 and October 2019 with specific lot numbers: 1901003HTT and 1810008HTT. Missing instructions to check for cracks are also a sign.
Inspect the device for cracks in the bowl, as this is a sign of the recalled product.
Reach out to Haemonetics for guidance on next steps if cracks are found or if the device is missing crack-check instructions.
The device may develop leaks at the inner core, causing fluid to trap inside the bowl and result in incomplete washing errors.
CS Elite Fastpack 225mL autotransfusion devices with bowl cracks or missing crack-check instructions from October 2014 to October 2019.
Check for bowl cracks or missing instructions to check for cracks. Affected units have specific lot numbers: 1901003HTT and 1810008HTT, manufactured between October 2014 and October 2019.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0894-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0894-2020 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.
