Haemonetics recalls Japan DISP SET models 263J and 205J (2014-2019) due to potential leaks in bowl sets causing device errors. Affected units may need replacement.
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 DISP SET models 263J and 205J (manufactured between October 2014 and October 2019) because bowl sets can leak, causing the device to show errors and potentially trap fluid inside. This could lead to incomplete cleaning of blood products during medical procedures.
The bowl sets can develop cracks, causing fluid to leak into the device. This may trigger an error message indicating the device is empty, potentially leading to incomplete cleaning of blood products during medical procedures.
Medical professionals using blood recovery systems during surgery or trauma care may own these units. Patients receiving blood processing services are at risk if the device malfunctions.
Check for specific lot numbers: 0718027-0119029-08170710119003, 0718027-0818086-08170711018045, 0718027-1118031-08170711118019, or 0718027-1118081-08170710119084. Products were sold between October 2014 and October 2019.
Inspect the bowl set for cracks as described in the instructions manual.
Reach out to Haemonetics for replacement or repair options.
Japan DISP SET models 263J and 205J manufactured between October 2014 and October 2019.
Bowl sets can develop cracks, causing leaks that may lead to device errors and incomplete blood processing.
No, but you should check for bowl cracks and contact Haemonetics for guidance.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0906-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0906-2020 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.
