Haemonetics recalls CS5/5+ Bowl Kit-125 mL Autotransfusion Devices with cracks or missing instructions that may cause leaks and device errors. Affected units were 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 CS5/5+ Bowl Kit-125 mL Autotransfusion Devices that may have cracks or missing instructions for checking cracks. This could cause leaks and device errors during blood processing.
Cracks in the bowl set can cause fluid to trap inside, leading to device errors and incomplete washing. This may affect blood processing accuracy during medical procedures.
Patients undergoing surgery or trauma treatment who use these devices are most at risk. The recall applies to specific lots manufactured between October 2014 and October 2019.
Check for cracks in the bowl set. The affected units were sold between October 2014 and October 2019 with specific lot numbers: 0119008, 0719045, 0819016, 1118051, 1118006, 0919022.
Inspect the bowl set for cracks, as this is a key indicator of the recalled product.
The recall is due to potential cracks in the bowl set that could cause leaks and device errors during blood processing.
Check for cracks in the bowl set. If you find cracks, contact Haemonetics for further instructions.
Specific lots manufactured between October 2014 and October 2019: 0119008, 0719045, 0819016, 1118051, 1118006, 0919022.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0886-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0886-2020 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.
