Merit Medical convenience kits recalled for syringe leaks and breakage
Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.
What this means for you
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 issues (leaks and breakage) that may pose a risk to patient health. No illnesses, injuries, or deaths have been reported, and the hazard remains theoretical. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Merit Medical Systems, Inc. is recalling 1,390 convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The kits, identified as K04 (Custom Syringe Kit, catalog number K04-00791A), contain syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. and have been distributed nationwide across the United States.
Leaks, breakage, and other quality issues have been identified in the recalled syringes. These quality defects may pose a risk to patient health, as the syringes are components of intravascular administration sets used to deliver fluids to patients' vascular systems.
The affected kits can be identified by the following lot numbers: H2387533, H2408714, H2423858, H2447173, H2484854, H2509065, H2547204, H2557351, H2640509, H2669424, H2704230, H2770492, H2780739, H2792326, H2864128, H2869756, and H2916432. The UDI-DI code is 00884450148471.
Individuals and healthcare facilities with these kits should check their lot numbers against the list provided. For questions or to report any issues with the recalled kits, contact Merit Medical Systems, Inc.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- leak
- breakage
- quality-defect
Distribution
Distributed nationwide across the United States.
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