FDA recall Z-2788-2017

Sorin Group USA, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-06-29
Report date: 2017-08-09
Termination date: 2021-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2788-2017