Haemonetics recalls CS Elite Fastpack 225mL blood recovery devices with potential leaks causing fluid traps and error messages. Affected units have specific lot numbers from Oct 2014 to 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 Fastpack 225mL blood recovery devices that may leak fluid inside the bowl, causing error messages and incomplete washing. This could lead to improper blood processing during medical procedures.
The device may develop cracks in the bowl, trapping fluid inside and causing error messages. This could lead to incomplete blood washing, potentially affecting the safety of the blood product used in medical procedures.
Patients undergoing surgery or trauma treatment who use this blood recovery device are most at risk. Medical facilities and patients with specific lot numbers from October 2014 to October 2019 are affected.
Check for specific lot numbers: 1902009HTT, 1903001HTT, 1903004HTT, 1804008HTT, 1804010HTT, 1805004HTT, 1805005HTT, 1812012HTT, 1901004HTT, 1901005HTT, 1901006HTT, 1808007HTT, 1808009HTT, 1808012HTT, 1809001HTT, 1809002HTT, 1809006HTT, 1809009HTT, 1810001HTT, 1810003HTT, 1901005HTT, 1902009HTT, 1810006HTT. Devices manufactured between October 2014 and October 2019 are affected.
Inspect the bowl for cracks, as damaged units may trap fluid and cause error messages.
Reach out to Haemonetics for assistance with the recall, as they provide specific guidance for affected units.
Haemonetics is recalling CS Elite Fastpack 225mL blood recovery devices that may leak fluid inside the bowl, causing error messages and incomplete washing.
Units with specific lot numbers from October 2014 to October 2019, including 1902009HTT, 1903001HTT, 1903004HTT, and others listed in the recall notice.
Check the lot number on your device against the list provided in the recall notice, which includes specific numbers from October 2014 to October 2019.
No, but you should check for cracks and contact Haemonetics if you have an affected unit to ensure proper handling.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0895-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-0895-2020 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.
