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

Recall Z-2785-2017 — SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA

U.S. FDA — Device Enforcement · United States · 2017-06-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2785-2017
Date of alert
2017-06-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sorin Group USA, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1620700048
Reported risk: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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