Merit Medical cardiac kits contain plastic syringes with quality defects
Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.
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 is a Class II medical device recall. The syringes may have leaks or breakage in cardiac procedures, posing a risk to patient health. No illnesses or injuries have been reported. Per the rubric, recalls of risk-of-harm products without reported injuries score as High (3).
Plain-English summary
Merit Medical Systems, Inc. is recalling various Prelude SNAP Introducer Catheter kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These convenience kits are used to introduce pacing leads and catheters to the heart and coronary venous system. Approximately 55,305 units were distributed nationwide across all U.S. states.
The recalled syringes have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health. These defects were identified in connection with an FDA Safety Alert issued on March 19, 2024.
Specific affected catalog numbers and lot numbers are provided in the FDA recall notice (Z-2574-2024). Healthcare providers with questions should contact Merit Medical Systems for further guidance and instructions.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- leakage
- breakage
Distribution
Distributed nationwide across the United States.
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