Haemonetics recalls Japan Cell Saver Elite Set 125ml products due to potential leaks in inner core causing device errors. Affected units were sold between October 2014 and October 2019. No remedy specified in recall notice.
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 Japan Cell Saver Elite Set 125ml products because leaks in the inner core could trap fluid, causing device errors. This risk affects medical devices used to process blood during surgery or trauma.
The inner core of the Cell Saver Elite set can develop leaks, trapping fluid inside the bowl. This may cause the device to display a long empty error message and prevent proper washing of blood components.
Medical professionals using the Japan Cell Saver Elite Set 125ml for blood processing during surgery or trauma are most at risk. Patients receiving blood transfusions through this device could be affected if leaks occur.
Check for the Japan Cell Saver Elite Set 125ml with catalog number CSE-P-125-JA. Products were sold between October 2014 and October 2019. The device is intended for blood recovery during surgery or trauma.
Inspect the inner core for cracks as missing instructions to check for cracks in the user manual may indicate a risk.
The recall indicates potential leaks could cause device errors, but no specific remedy is provided. Users should check for cracks as instructed.
Products were sold between October 2014 and October 2019.
The catalog number is CSE-P-125-JA.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0903-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0903-2020 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.
