Z-0410-2024 Class II Ongoing
FDA device recall Z-0410-2024 was initiated by Edwards Lifesciences, LLC on October 4, 2023 and is designated Class II. Reason for recall: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. The recall status is ongoing. Affected quantity: 6,714 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,714 units
Product Description
Reason for Recall
Distribution Pattern
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