Haemonetics recalls Cell Saver 5/5+ Bowl Kit (225 ml) autotransfusion devices with bowl cracks or missing crack-check instructions. Leaks may cause fluid trapping and device errors during blood processing.
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 Cell Saver 5/5+ Bowl Kit (225 ml) autotransfusion devices that may have cracks in the bowl or missing instructions to check for cracks. This could lead to fluid trapping and device errors during blood processing, potentially causing incomplete washing of blood.
Bowl cracks in the Cell Saver 5/5+ or Elite models can trap fluid inside the bowl, causing the device to display a long empty error message. This may result in incomplete blood washing during medical procedures.
Medical professionals using the Cell Saver 5/5+ Bowl Kit (225 ml) autotransfusion device for blood recovery during surgery or trauma. Those who purchased the device between October 2014 and October 2019 are most at risk.
Check for cracks in the bowl of the Cell Saver 5/5+ Bowl Kit (225 ml) autotransfusion device. The affected units were manufactured between October 2014 and October 2019 and include specific lot numbers: 0119010, 0119011, 0219031, 0218056, 0218057, 0218058, 0418012, 1018084, 1118009, 0718099.
Inspect the bowl for cracks, as this is a known issue with the recalled units.
Reach out to Haemonetics Corporation for further guidance on the recall.
The hazard is potential leaks at the inner core of the Cell Saver 5/5+ and Elite models due to bowl cracks, which can trap fluid and cause device errors during blood processing.
Affected lots include 0119010, 0119011, 0219031, 0218056, 0218057, 0218058, 0418012, 1018084, 1118009, and 0718099.
The affected units 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-0891-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0891-2020 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.
