LivaNova USA: Medical Device Recall in 2018 - (Recall #: Z-0664-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: December 19, 2017

Date Posted: February 28, 2018

Recall Number: Z-0664-2018

Event ID: 79000

Reason for Recall:

The product is labeled with the incorrect expiration date.

Status: Terminated

Product Quantity: 16 units (6 from lot 1717800062 and 10 units from lot 1720800071

Code Information:

Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071

Distribution Pattern:

Distribution was made to one consignee in LA.

Voluntary or Mandated:

Voluntary: Firm initiated