Merit Medical convenience kits with recalled plastic syringes may leak or break
Convenience kits from Merit Medical Systems containing recalled plastic syringes have identified quality issues including leaks and breakage that may pose a risk to patient health.
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 medical device with identified quality hazards (leaks and breakage) in syringes used during invasive procedures. No reported patient injuries. Meets rubric criterion for risk-of-harm products where injury has not been documented.
Plain-English summary
Merit Medical Systems is recalling medical convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These kits are designed to support fluid administration and physiological pressure monitoring during vascular or cardiac diagnostic and interventional procedures.
The FDA has identified leaks, breakage, and other quality issues in the recalled syringes, as documented in the FDA Safety Alert issued on March 19, 2024. These quality defects may pose a risk to patient health.
Approximately 168,157 affected kits have been distributed nationwide across all U.S. states. Healthcare facilities and medical providers with these recalled kits should contact Merit Medical Systems for guidance on product handling and replacement.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 168,157
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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