Merit Medical Convenience Kits with Defective Syringes Recalled
Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing 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: This is an FDA Class II recall of medical syringes with reported leaks, breakage, and quality issues used in critical cardiac and vascular procedures. No illnesses or injuries have been reported. Per the severity rubric, this meets the criterion of 'risk-of-harm products where injury has not yet been reported,' scoring 3 (High).
Plain-English summary
Merit Medical Systems, Inc., is recalling medical convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The recalled kits are used in vascular and cardiac diagnostic and interventional procedures. The syringes are affected by an FDA Safety Alert issued on March 19, 2024, due to reports of leaks, breakage, and other quality issues.
The recall affects 13,560 kits distributed nationwide across all U.S. states. Multiple catalog numbers are affected, including K05-00203M, K05-00511J, K05-00547J, K05-00612Q, K05-00819A, K05-01030H, K05-01274D, K05-01646, K05-01688A, K05-01717B, K05-01880K, K05-01890D, K05-01945A, K05-01954A, K05-02247A, K05-02436B, K05-02507, K05-02511A, K05-02954, and K05-02982A, with specific lot numbers listed for each.
Healthcare facilities and customers who have received these kits should verify whether they are affected using the provided catalog and lot numbers. Contact Merit Medical Systems for information on verification, replacement, or return options.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 13,560
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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