Haemonetics recalls certain Cell Saver bowl sets that may leak fluid, causing device errors and incomplete washing. Affected units were sold between October 2014 and October 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 specific blood processing bowl sets that could leak fluid, leading to device errors and incomplete washing. This affects devices used in medical procedures like surgery or trauma care.
Leaking fluid in the bowl core can cause the device to show a long empty error message and may result in incomplete washing of blood components. This could affect the safety and effectiveness of blood processing procedures.
Medical professionals using these devices during surgery or trauma care are most at risk. Patients receiving blood processing from these devices may also be affected.
Check for the model name 'Cell Saver 5/5+' or 'Elite/Elite +125ml and 225ml bowl sets' with catalog number 0263A-00. Products were sold between October 2014 and October 2019.
Inspect the bowl set for cracks as missing instructions may not have covered this check.
Cell Saver 5/5+ Bowl Set Autotransfusion Device and related accessory components.
Between October 2014 and October 2019.
The recall does not specify a fix; users should check for cracks and contact Haemonetics for further guidance.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0887-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0887-2020 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.