Haemonetics recalls CS Elite Processing Set (125ml) autotransfusion devices with bowl cracks or missing crack-check instructions due to potential leaks causing device errors. Affected units 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 CS Elite Processing Sets (125ml) autotransfusion devices that may have cracks in the bowl or missing instructions to check for cracks. This could cause leaks, leading to device errors and incomplete blood washing.
Cracks in the bowl can cause fluid to trap inside, triggering a 'long empty device' error message. This may result in incomplete blood washing, potentially affecting patient safety during transfusion procedures.
Patients undergoing surgery or trauma who use this blood processing device are most at risk. The recall affects units sold between October 2014 and October 2019.
Check for cracks in the bowl of the CS Elite Processing Set (125ml) device. Units sold between October 2014 and October 2019 with specific lot numbers (0119014, 0119015, 0719047, 0719060, 0819014, 0819032) are affected.
Inspect the bowl for cracks as part of the device's instructions.
Confirm the product lot number matches the affected lots listed in the recall notice.
The recall is due to potential bowl cracks causing fluid leaks, which may lead to device errors and incomplete blood washing.
Check for bowl cracks and verify the product lot number against the affected lots listed in the recall notice.
Yes, affected lots include 0119014, 0119015, 0719047, 0719060, 0819014, and 0819032.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0893-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0893-2020 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.
