Merit Medical Convenience Kits with Defective Syringes Recalled
Merit Medical convenience kits containing defective syringes are being recalled for leaks and breakage that 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: FDA Class II recall of medical device syringes with identified defects (leaks and breakage). These are risk-of-harm products used in invasive medical procedures, though no illnesses or injuries have been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling various Prelude Prestige convenience kits (catalog numbers PLP-2505/A, PLP-2514/A, and PLP-2516/A) that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The syringes are used to introduce pacing and defibrillator leads into the venous vasculature.
The FDA identified leaks, breakage, and other quality issues with the syringes through a Safety Alert issued on March 19, 2024. These defects may pose a risk to patient health.
Approximately 30 kits have been distributed nationwide. Affected lot numbers are I2889564, I2902220, and I2894297.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters i
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- Hazard
- leakage
- breakage
Distribution
Distributed nationwide across the United States.
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