Haemonetics recalls Japan Low Vol 125ml CS5 Set (Lot 118011) due to bowl cracks causing leaks. This may lead to device errors and incomplete blood 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 Low Volume 125ml CS5 Set (Lot 118011) because bowl cracks can cause leaks. This may result in the device showing an error message and incomplete blood washing, which could affect patient safety during blood recovery procedures.
Bowl cracks in the CS5 Set can cause leaks, trapping fluid inside the bowl. This may trigger a long empty device error message and lead to incomplete blood washing during medical procedures.
Patients undergoing blood recovery procedures using this specific CS5 Set model are most at risk. The affected units were sold between October 2014 and October 2019 in Japan.
Check for cracks in the bowl of the CS5 Set. The affected model was sold in Japan between October 2014 and October 2019 with catalog number FG-0261J-00.
Inspect the bowl for cracks, as this is a key indicator of the recalled item.
The CS5 Set may have bowl cracks causing leaks, which can lead to device errors and incomplete blood washing during medical procedures.
The recalled product is the Japan Low Vol 125ml CS5 Set with catalog number FG-0261J-00.
The affected units were 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-0897-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0897-2020 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.
