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Terminated

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.

FDA Recall Z-0664-2018 · Posted None

Recalling FirmLivaNova USA
Recall StatusTerminated
Product CodeDWE
Date Initiated2017-12-19
Date Terminated2020-08-11
Product Quantity16 units (6 from lot 1717800062 and 10 units from lot 1720800071

Reason for Recall

The product is labeled with the incorrect expiration date.

Firm Action

The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.

Root Cause

Process control

Distribution Pattern

Distribution was made to one consignee in LA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981613COBE SMARXT TUBING AND CONNECTORSCobe Cardiovascular, Inc. · 1998-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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