Sorin Group Smart Perfusion Pack E-Pack recall
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…
Why was Sorin Group Smart Perfusion Pack E-Pack recalled?
The product is labeled with the incorrect expiration date.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
- Product
- 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…
- Recalling firm
- LivaNova USA
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Distribution
- Distribution was made to one consignee in LA.
- Recall date
- February 28, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)