Merit Medical Catheter Kits Recalled for Syringe Leaks and Breakage Issues
Merit Medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects approximately 4,027 kits distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses or injuries. The hazard involves quality defects (leaks and breakage) in medical syringes used in cardiac catheterization procedures, which present a credible risk to patient safety but have not yet resulted in reported harm.
Plain-English summary
Merit Medical Systems is recalling various medical convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The specific products are SafeSheath CSG and Worley advanced CSG Introducer Catheter kits, designed for introduction of pacing or defibrillator leads and catheters during cardiac procedures.
The recalled syringes are subject to an FDA Safety Alert issued on March 19, 2024, due to identified leaks, breakage, and other quality issues that may pose a risk to patient health. Approximately 4,027 kits have been distributed nationwide across the United States. Multiple catalog numbers and lot numbers are affected; detailed information is available through the FDA.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 4,027
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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