Haemonetics recalls Japan Disp Set models 261J, 205J, 208 due to potential leaks from bowl sets causing device errors. Affected units may have cracks or missing instructions for checking cracks.
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 261J, 205J, and 208 because bowl sets can leak, leading to device errors and incomplete washing of blood. This could affect patients receiving blood treatments.
The bowl sets in these models can develop leaks, trapping fluid inside the bowl core. This may cause the device to show a long empty error message and result in incomplete washing of blood, potentially affecting treatment safety.
Patients undergoing blood treatments or surgeries who use these specific Haemonetics Japan Disp Set models. Those with bowl sets that have cracks or missing instructions for checking cracks are most at risk.
Check for bowl sets with cracks or missing instructions to check for cracks. Affected models are 261J, 205J, and 208, distributed between October 2014 and October 2019. Lot numbers include ranges like 1118011-0119029-190124H2.
Inspect the bowl set for cracks, as this is a known issue with affected units.
The recall is due to potential leaks from bowl sets that can trap fluid, causing device errors and incomplete washing of blood during treatment.
Models 261J, 205J, and 208, distributed between October 2014 and October 2019.
Look for cracks in the bowl set; affected units may also have missing instructions to check for cracks.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0899-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0899-2020 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.
