Convenience kits by Merit Medical recalled for syringe defects
Merit Medical convenience kits containing defective syringes have been recalled nationwide. Identified quality issues including leaks and breakage may pose risks during cardiac and vascular 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 recall of medical devices used in critical cardiac and vascular procedures. Identified quality defects (leaks and breakage) present a risk of harm to patients. No illnesses or injuries have been reported, placing this at High rather than Severe severity.
Plain-English summary
Merit Medical Systems, Inc. has recalled convenience kits containing syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The kits are used for cardiac and vascular diagnostic and interventional procedures.
The recalled syringes have been identified with quality issues including leaks and breakage. These defects may pose a risk to patient health. The recall was prompted by an FDA Safety Alert issued on March 19, 2024.
The affected kits were distributed nationwide to healthcare facilities across all U.S. states.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 34,197
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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