Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage
Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.
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 risk-of-harm medical device recall without reported illnesses or injuries. The source identifies potential hazards (leaks, breakage, quality defects) but does not report any actual harm. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a score of 3 (High).
Plain-English summary
Merit Medical Systems is recalling various medical convenience kits containing plastic syringes from Jiangsu Shenli Medical Production Co. Ltd. The affected kits include catalog numbers K02-00873A, K02-01105A, and K02-01481A, with specific lot numbers identified by the FDA.
The FDA identified quality defects including leaks, breakage, and other quality issues in the syringes. These defects may pose a risk to patient health when the syringes are used to inject or withdraw fluids from the body. The recall impacts approximately 3,647 kits that were distributed nationwide throughout the United States.
Anyone who has received these recalled kits should discontinue use 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: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 3,647
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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