Sorin Group USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2787-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA

Product Classification:

Class II

Date Initiated: June 29, 2017

Date Posted: August 9, 2017

Recall Number: Z-2787-2017

Event ID: 77810

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.

Status: Terminated

Product Quantity: 632 units

Code Information:

Lot numbers: 1620200038, 1621700037, 1622800048, 1623100036, 1623700036, 1625700047, 1627900048, 1630500054, 1630600077, 1631900048, 1632700043, 1633500024, 1701000056, 1701600055, 1701800042 1704500037, 1705300070, 1706100042, 1707600055, 1706600103, 1707900056, 1708900035, 1710700038, 1712400062, 1713600042, 1714400058, 1715200088, 1715800067

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated