Blood Management System Pressure Tubing May Detach
Edwards Lifesciences blood management system (VJ0990) pressure tubing may detach from the blood sampling system during use. The recall affects 2,000 units distributed across the U.S., Canada, UK, and Italy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a blood management system with pressure tubing that may detach during use, representing a risk-of-harm to patients. No illnesses or injuries have been reported, which places this in the High (Score 3) category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Edwards Lifesciences is recalling its VJ0990 Blood Management System, a sterile, single-use medical device. The recall involves 2,000 units bearing Lot # 63456332.
The recalled units have a potential defect: the pressure tubing may detach from the blood sampling system during use. This tubing detachment could disrupt blood management operations and pose a safety risk in clinical settings.
The recall affects units distributed to healthcare facilities across 30 U.S. states, the District of Columbia, Puerto Rico, Canada, the United Kingdom, and Italy.
Facilities that have received affected units should contact Edwards Lifesciences for instructions on inventory verification and appropriate handling of the recalled devices.
The recalled product
- Product
- Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- tubing-detachment
- equipment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 63456332
Distribution
Distributed in 33 states:
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- ID
- IL
- IN
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NJ
- PR
- SD
- TX
- UT
- VA
- WA
- WI
- WV
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