Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled
Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were 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 involving defects (leaks and breakage) in medical syringes used for vascular and cardiac procedures. No injuries or hospitalizations reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Merit Medical Systems, Inc. is recalling 69 convenience kits (K11 Custom Pressure Monitoring Kit, Catalog Number K11-00382C) that contain syringes from Jiangsu Shenli Medical Production Co. Ltd. The FDA identified leaks, breakage, and other quality issues with the syringes that may pose a risk to patient health.
These kits support fluid administration and physiological pressure monitoring for various vascular and cardiac diagnostic and interventional procedures. The recalled kits were distributed nationwide throughout the United States.
Affected lot numbers are H2379628, H2531736, H2536619, H2813488, H2881603, and H2916468. Healthcare providers and patients with these lot numbers should discontinue use immediately and contact Merit Medical Systems, Inc. for instructions on replacement or return of the recalled product.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 69
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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