Reported Feb 5, 2020 · Terminated
JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the…
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?
- JAPAN BASIC HI SPEED CS5 SET
- LN 263J - Product Usageits related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 0263J-001. Specific — Lot with Bowl Cracks (814 Distributed) — Lot number: 0718027 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019. - Amount recalled
- 28462
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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