Merit Medical Convenience Kits Recalled for Defective Plastic Syringes
Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing 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: This is an FDA Class II medical device recall with no reported hospitalizations or illnesses. The hazard involves quality defects in syringes that pose a theoretical risk of patient harm. Per the rubric, a Class II recall without reported illness in a risk-of-harm product scores as High (3).
Plain-English summary
Merit Medical Systems, Inc. is recalling various ReSolve medical convenience kits, specifically designed for thoracic procedures. These kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that were affected by an FDA Safety Alert issued on March 19, 2024.
The recalled syringes have been identified with quality issues including leaks, breakage, and other defects. These problems may pose a risk to patient health during medical procedures.
Approximately 7,442 affected kits have been distributed nationwide across all U.S. states and territories. Healthcare facilities and providers who have received these kits should immediately stop using them and contact Merit Medical Systems for further guidance.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kit
- Affected units
- 7,442
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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