Merit Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.
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: FDA Class II medical device recall involving syringes with identified quality defects (leaks, breakage) used in invasive cardiovascular procedures. This constitutes a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling medical convenience kits used for angiography and angioplasty procedures. These kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that are affected by an FDA Safety Alert issued on March 19, 2024.
The recalled syringes have identified leaks, breakage, and other quality defects that may pose a risk to patient health. Affected kits were distributed nationwide throughout the United States.
Healthcare facilities should stop using these kits immediately. Patients or healthcare providers with questions should contact Merit Medical Systems for information about replacements or returns.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 1,753,625
Distribution
Part of a larger recall action
This product is one of 23 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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