FDAFDA · Food and drugs·Recall number Z-0664-2018
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Published February 28, 2018 · Recall initiated: December 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product is labeled with the incorrect expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LivaNova USA
- Distributor
- Distribution was made to one consignee in LA.
- Lot
- Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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