FDA-Device2017-08-09Class II
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Sorin Group USA, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
733 units
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2788-2017Don't want to check this manually?
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