Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks
Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.
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 of syringes with documented leaks and breakage that may cause harm. No hospitalizations or injuries reported. Rates as High (3) because it is a quality-defect risk-of-harm product without reported illness, per rubric criteria.
Plain-English summary
Merit Medical Systems, Inc. is recalling convenience kits used in cardiac and vascular diagnostic and interventional procedures. These kits contain syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that are subject to a March 19, 2024 FDA Safety Alert. The recalled Custom Procedure Kits include catalog numbers K12T-10773, K12T-09284D, K12T-10621, K12T-10800, and K12T-12491.
The syringes in these kits have quality defects—specifically leaks, breakage, and other quality issues—that may pose a risk to patient health.
Approximately 11,837 kits have been distributed nationwide throughout the United States.
Patients and healthcare providers should not use the recalled kits. Check whether you have products with the listed catalog numbers and lot numbers. Contact Merit Medical Systems for assistance, or refer to FDA Medical Device Recall Z-2558-2024 for additional details.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 11,837
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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