Haemonetics recalls Japan Cell Saver Elite Set (225ml) due to potential leaks from bowl cracks causing device errors. Affected units include specific lots manufactured between Oct 2014 and 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 Japan Cell Saver Elite Set (225ml) products that may have bowl cracks. These cracks can cause leaks, leading to device errors and incomplete washing of blood products.
Bowl cracks in the 225ml set can cause leaks, trapping fluid inside the bowl. This may trigger a long empty device error message and lead to incomplete washing of blood products.
Medical professionals using the Japan Cell Saver Elite Set for blood recovery during surgeries or trauma. Those with specific lots manufactured between October 2014 and October 2019 are most at risk.
Check for cracks in the bowl of the Japan Cell Saver Elite Set (225ml). Affected units include specific lots: 1118017 and 0718009, manufactured between October 2014 and October 2019.
Inspect the bowl for visible cracks, as these can cause leaks and device errors.
Bowl cracks can cause leaks, trapping fluid inside the bowl and leading to device errors and incomplete washing of blood products.
Specific lots: 1118017 and 0718009, manufactured between October 2014 and October 2019.
Check for cracks in the bowl and verify the lot number is one of 1118017 or 0718009, with production dates 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-0904-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0904-2020 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.
