Heart Lung Pack and Cardiovascular Oxygentor Packs (2018-11-07)
- Starting date:
- November 7, 2018
- Posting date:
- November 30, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68474
Affected products
A. Heart Lung Pack
B. Cardiovascular Oxygentor Packs
Reason
LivaNova has identified that 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing system packs indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours may leak or be occluded. LivaNova is voluntarily informing its customers and will offer the possibility to replace the defective stopcocks.
Affected products
A. Heart Lung Pack
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
025XXXXXX
627203801
Companies
- Manufacturer
-
LivaNova USA, Inc.
14401 WEST 65th Way
Arvada, Colorado
80004
Colorado
UNITED STATES
B. Cardiovascular Oxygentor Packs
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
046000900
Companies
- Manufacturer
-
LivaNova USA, Inc.
14401 WEST 65th Way
Arvada, Colorado
80004
Colorado
UNITED STATES