Merit Medical pericardiocentesis kits recalled for syringe defects
Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage 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: This FDA Class II recall involves medical devices used in high-risk cardiac procedures with documented quality issues (leaks and breakage). Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Merit Medical Systems, Inc. is recalling 72,115 convenience kits containing plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The affected kits include various pericardiocentesis tray models (PC101/B, PC201/B, PC801, PC801/A, PC802, PC802/A) designed to withdraw fluid from the pericardial sac (the membrane surrounding the heart).
These syringes are subject to an FDA safety alert issued on March 19, 2024. The syringes have quality issues including leaks, breakage, and other defects that may pose a risk to patient health when used in cardiac procedures.
The convenience kits have been distributed nationwide across all U.S. states.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 72,115
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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