Reported Feb 5, 2020 · Terminated
CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are…
Haemonetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haemonetics Corporation · 400 Wood Rd · Braintree, MA · 02184-2412
Is this the product you have?
CS Elite Fastpack225 mL150 Res
- Autotransfusion Device - Product Usageits related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient
- Lot codes and dates
- Catalog number/FG Item NumberCSE-FP-225V 1. Specific Lots with Bowl
- Cracks (7636 Distributed) Lot number2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019
1902009HTT1903001HTT1903004HTT1804008HTT1804010HTT1805004HTT1805005HTT1812012HTT1901004HTT1901005HTT1901006HTT1808007HTT1808009HTT1808012HTT1809001HTT1809002HTT1809006HTT1809009HTT1810001HTT1810003HTT1901005HTT1902009HTT1810006HTT
- Amount recalled
- 42739
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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