Devices

Device Recall SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA3D

Model / Serial
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
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
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
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA3D

Manufacturer

Sorin Group USA, Inc.

Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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