Haemonetics recalls JAPAN CS Elite Fastpack 225ml units with bowl cracks that may leak blood during blood recovery procedures. Affected units have specific lot numbers from October 2014 to 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 CS Elite Fastpack 225ml blood recovery devices that may have cracks in the bowl, causing leaks and potential incomplete washing. This could lead to errors in blood processing during medical procedures.
Cracks in the bowl can cause blood to leak, leading to incomplete washing and device errors. This may result in improper blood processing during medical procedures.
Medical professionals using blood recovery devices for surgery or trauma treatment. Patients receiving blood transfusions via these devices are at risk if the device leaks.
Check for cracks in the bowl of the JAPAN CS Elite Fastpack 225ml device. Affected units were manufactured between October 2014 and October 2019 with specific lot numbers listed in the recall notice.
Inspect the bowl for cracks, as this is a key indicator of the recalled product.
Reach out to Haemonetics for guidance on next steps if cracks are found.
The recall is due to potential bowl cracks that could cause leaks and incomplete washing during blood recovery procedures.
Check for bowl cracks and contact Haemonetics for guidance if cracks are present.
Products were 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-0902-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0902-2020 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.
