Haemonetics recalls Japan Basic Hi Speed CS5 Set (LN 263J) due to potential leaks in bowl sets that could cause device errors and incomplete washing. Affected units were sold 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 its Japan Basic Hi Speed CS5 Set (LN 263J) because bowl sets might leak, causing the device to show errors and potentially not wash blood properly. This could affect patients receiving blood treatments.
Bowl sets in the CS5 Set might develop cracks, leading to leaks. This can cause the device to display an error message and fail to properly wash blood, potentially leaving blood residue inside the system.
Patients undergoing blood treatments or surgeries who use the CS5 Set are most at risk. The recall applies to units sold between October 2014 and October 2019.
Check for bowl sets with cracks or missing instructions to check for cracks. The affected units were sold between October 2014 and October 2019 with catalog number 0263J-00.
Inspect the bowl sets for cracks, as this is a known issue with the recalled units.
The CS5 Set bowl sets may develop cracks, causing leaks that lead to device errors and incomplete blood washing.
Check for bowl cracks. If you find cracks, stop using the product immediately.
The affected units were sold 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-0898-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0898-2020 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.
