Haemonetics recalls CS5/5+ Fastpacks with bowl cracks that may cause leaks and device errors. Affected units include specific lots from Oct 2014 to 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 CS5/5+ Fastpacks with bowl cracks that could cause leaks and device errors. This affects specific lots manufactured between October 2014 and October 2019. The recall is important because leaks might trap fluid inside the device, leading to incomplete washing and potential errors.
Bowl cracks in the CS5/5+ Fastpacks can cause leaks, trapping fluid inside the device. This may lead to a long empty device error message and incomplete washing of blood components.
Medical professionals using the CS5/5+ Fastpacks for blood recovery during surgery or trauma are most at risk. Patients receiving these devices could experience incomplete washing if leaks occur.
Check for cracks in the bowl of the CS5/5+ Fastpack. Affected units were manufactured between October 2014 and October 2019 and include specific lot numbers listed in the recall notice.
Inspect the bowl for visible cracks, as this is a key indicator of the recalled units.
Haemonetics is recalling CS5/5+ Fastpacks with bowl cracks that could cause leaks and device errors, affecting specific lots manufactured between October 2014 and October 2019.
Check for cracks in the bowl and verify your lot number against the list provided in the recall notice, which includes specific lots from October 2014 to October 2019.
The recall only applies to units with bowl cracks. If your device has no cracks, it is not affected by this recall.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0885-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0885-2020 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.
