Device product
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Z-2785-2017
Product summary
- Event
- Event 77810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 524 units
- Official record key
device-enforcement:Z-2785-2017
Official wording
Reason: 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.
Code information: Lot Numbers: 1620700048, 1621600063, 1623700039, 1624500038, 1625900047, 1626500084, 1627800066, 1628500062, 1630000040, 1630500055, 1631400035, 1633300052, 1635400049, 1700600038, 1702500069, 1704500039, 1706600107, 1707400082, 1708600072, 1710800102, 1711700034, 1713600045, 1715000038, 1717000046
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
sterile barrier breach