FDA recalls Merit Medical convenience kits due to defective syringes
Merit Medical convenience kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits are used for vascular and cardiac 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 identified quality defects (leaks and breakage). No illnesses or injuries are reported; the hazard is theoretical. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling various convenience kits containing plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These kits are used to support fluid administration and various vascular and cardiac diagnostic and interventional procedures.
The FDA identified leaks, breakage, and other quality issues in the recalled syringes. These defects may pose a risk to patient health during medical procedures.
The recall involves 188,837 convenience kits distributed nationwide across the United States. The FDA has identified specific catalog numbers and lot numbers for the affected products.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 188,837
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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