Haemonetics recalls Japan Disp Set models 261J and 205J due to potential leaks in blood processing units that could cause device errors and incomplete washing. Affected units may have bowl cracks or missing instructions for crack checks.
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 specific blood processing units (JAPAN DISP SET models 261J and 205J) because bowl cracks can cause leaks, leading to device errors and incomplete washing. This could affect patients receiving blood treatments.
Bowl cracks in the blood processing units can cause leaks, trapping fluid inside the bowl. This may trigger a long empty device error message and result in incomplete washing of blood products, potentially affecting patient safety.
Patients undergoing blood processing procedures using these specific models are most at risk. Healthcare facilities that use these units for blood recovery and processing may also be affected.
Check for bowl cracks in the JAPAN DISP SET units (models 261J and 205J). Products were manufactured between October 2014 and October 2019 and may have missing instructions to check for cracks.
Inspect the bowl for cracks, as this is a known issue with affected units.
Ensure you have the instructions to check for bowl cracks, as some units may lack this information.
JAPAN DISP SET models 261J and 205J were recalled between October 2014 and October 2019.
The recall is due to potential bowl cracks that can cause leaks, leading to device errors and incomplete washing of blood products.
Check for bowl cracks and ensure the unit was manufactured 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-0900-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0900-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
