Z-2788-2017 Class II Terminated
FDA device recall Z-2788-2017 was initiated by Sorin Group USA, Inc. on June 29, 2017 and is designated Class II. 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 pote… The recall status is terminated (terminated April 12, 2021). Affected quantity: 733 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- April 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 733 units
Product Description
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 Pattern
Nationwide
Code Information
Lot Numbers: (a) 1703100033, 1703200057, 1705400037, 1707900050, 1708200042, 1710200084, 1713700057, 1715900028 (b) 1619500015, 1620300020, 1623000025, 1623700026, 1624400017, 1625100125, 1626500068, 1627900033, 1628600023, 1629400030, 1632800035, 1634200023, 1634900050, 1635600025, 1700300019, 1700500032, 1702300048, 1703200053, 1703900069