Haemonetics recalls CS Elite Processing Set (225 ml) autotransfusion devices with potential leaks in bowl sets that may cause incomplete washing and device errors.
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 CS Elite Processing Set (225 ml) autotransfusion devices that have a risk of leaks in the bowl sets. This could lead to incomplete washing of blood and device errors, which may affect patient safety during medical procedures.
The bowl sets in specific lots may develop cracks, causing fluid to trap inside the bowl. This can lead to device errors indicating incomplete washing, potentially affecting the safety of blood processing for patients.
Medical professionals using the CS Elite Processing Set for blood recovery during surgeries or trauma treatments. Patients receiving transfusions using these devices are at risk if the bowl sets leak.
Check for cracks in the bowl sets. The affected lots are 0718008, 0818052, 0818110, 0119048, and 0218064. Products were sold between October 2014 and October 2019.
Inspect the bowl sets for cracks, as these can cause leaks and device errors.
The bowl sets in specific lots may develop cracks, causing fluid to trap inside and leading to device errors indicating incomplete washing.
Affected lots are 0718008, 0818052, 0818110, 0119048, and 0218064.
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-0892-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0892-2020 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.
