Merit Medical Convenience Kits with Recalled Syringes Pose Leak Risk
Merit Medical is recalling 900 convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues 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 recall of medical syringes with identified quality defects (leaks, breakage) used in critical medical procedures. No illnesses or injuries have been reported, consistent with a risk-of-harm product recall without reported harm.
Plain-English summary
Merit Medical Systems, Inc. is recalling 900 convenience kits containing plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These kits are used for introducing various types of pacing and defibrillator leads and catheters. The syringes are affected by an FDA Safety Alert issued on March 19, 2024, due to identified leaks, breakage, and other quality issues.
The identified defects may pose a risk to patient health during medical procedures requiring the introduction of pacing or defibrillator leads and catheters.
The affected kits have been distributed nationwide across the United States.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 900
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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