Reported Feb 28, 2018 · Terminated
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is…
LivaNova USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: LivaNova USA · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- Sorin Group Smart Perfusion Pack E-Pack, REF 088511400
- RevL, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO
- Lot codes and dates
- Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
- Amount recalled
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Where it was sold
Why it was recalled
The product is labeled with the incorrect expiration date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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