Reported Feb 5, 2020 · Terminated
JAPAN DISP SET, 261J, 205J, 208 - 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 DISP SET261J205J208 -
- 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
- Catalog number/FG Item Number261J-SET 1. Specific Lots with Bowl Cracks (1819
- Distributed) FP Lot numbers1118011-0119029-190124H2; 1118011-0119030-190125H1; 1118011-1118031-181226H1; 1118011-1118032-181226H1; 1118011-1118081-190124H1; 1118011-1118082-190124H1; 1118011-1118082-190124H2; 1118011-1118083-190124H2 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019
- Amount recalled
- 25529
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Haemonetics Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.