Haemonetics recalls Japan DISP SET models 263J, 205J, and 208 due to potential leaks in bowl sets that may cause device errors. Affected units were sold between October 2014 and October 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 Japan DISP SET models 263J, 205J, and 208 because bowl sets can leak, causing device errors. This could lead to incomplete washing of blood components during medical procedures.
Bowl sets in these devices can develop cracks, trapping fluid inside and causing the device to show an error message. This may result in incomplete washing of blood components during medical procedures.
Medical professionals using these blood recovery devices in Japan are most at risk. Units sold between October 2014 and October 2019 are affected.
Check for bowl cracks in the device. Affected units were sold in Japan between October 2014 and October 2019 with specific lot numbers listed in the recall notice.
Inspect the bowl set for cracks, as this is a key indicator of the issue.
Reach out to Haemonetics for further guidance on the recall and potential remedies.
Japan DISP SET models 263J, 205J, and 208 sold between October 2014 and October 2019.
Bowl sets can develop cracks, trapping fluid and causing device errors that may lead to incomplete washing of blood components.
Check for bowl cracks and verify the product was sold between October 2014 and October 2019 in Japan.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0905-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0905-2020 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.
