Medical paracentesis procedure kits recalled for syringe leaks and breakage
Merit Medical is recalling paracentesis procedure kits nationwide containing syringes with identified leaks and breakage. The defects may pose a risk to patient health during medical procedures.
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 a Class II medical device recall with identified quality defects (leaks and breakage) in syringes used in medical procedures. No illnesses or injuries have been reported, making the hazard real but the harm theoretical, which per the rubric qualifies as High severity for risk-of-harm products without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling various Safety Paracentesis Procedure Tray kits and related medical convenience kits distributed nationwide. These kits contain syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that were subject to an FDA Safety Alert issued on March 19, 2024.
The recalled syringes have been identified with quality defects including leaks and breakage. These defects may pose a risk to patient health and proper function of the devices during medical procedures such as fluid drainage and specimen collection.
Approximately 317,115 affected kits have been distributed throughout the United States, including to healthcare facilities in all 50 states and the District of Columbia.
No illnesses or injuries have been reported to date. Healthcare providers using these products should contact Merit Medical Systems, Inc. for information regarding replacement or return of affected kits.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SP
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 317,115
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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