Device product
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Z-2784-2017
Product summary
- Event
- Event 77810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98 units
- Official record key
device-enforcement:Z-2784-2017
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: 1620000123, 1622800056, 1623500052m 1627700083, 1631200074, 1700300040, 1701000065, 1703700061, 1706500063, 1708000068, 1717000057
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
sterile barrier breach