Haemonetics recalls Japan CS Elite FASTPACK 125ml sets with bowl cracks or missing crack-check instructions. Leaks may cause device errors and incomplete washing. Affected units 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 Japan CS Elite FASTPACK 125ml blood collection sets that may have cracks in the bowl, which could cause leaks and device errors. This affects units sold between October 2014 and October 2019, and could lead to incomplete blood washing if not fixed.
Cracks in the bowl can cause fluid to leak into the device, leading to error messages and incomplete blood washing. This may result in improper blood processing and potential safety risks during medical procedures.
Patients undergoing blood procedures or trauma treatment who use these sets are most at risk. Healthcare providers using the sets for blood recovery during surgery or trauma are affected.
Check for cracks in the bowl of the Japan CS Elite FASTPACK 125ml set. Products sold between October 2014 and October 2019 with lot numbers starting 0719048-0219057190329H10119100 may be affected.
Inspect the bowl for cracks, which could cause leaks and device errors.
Reach out to Haemonetics for guidance on next steps if cracks are found.
The recall is due to potential bowl cracks causing leaks and device errors, which may lead to incomplete blood washing during medical procedures.
Check for cracks and contact Haemonetics for guidance on next steps.
Products 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-0901-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0901-2020 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.
