Product Wiki · Recalls · U.S. FDA — Device Enforcement

Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L… — recall Z-0664-2018

U.S. FDA — Device Enforcement · United States · 2017-12-19 · Class III

As described by U.S. FDA — Device Enforcement: 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.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0664-2018
Date of alert
2017-12-19
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
LivaNova USA
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distribution was made to one consignee in LA.
Reported risk: The product is labeled with the incorrect expiration date.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.