Various Merit Medical convenience kits containing Jiangsu Shenli Medical Production Co. Ltd. syringes (K22C) are recalled due to leaks, breakage, and quality issues that may pose patient health risks. Affected kits include specific model numbers and lot numbers listed in the recall.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Merit Medical has recalled convenience kits that contain syringes made by Jiangsu Shenli Medical Production Co. Ltd. The syringes (model K22C) have been identified by the FDA as having leaks, breakage, and quality issues that could harm patients. These kits are used for vascular or cardiac diagnostic procedures.
The syringes in these kits have been identified by the FDA as having leaks, breakage, and quality issues. These problems could lead to patient injury or health risks during medical procedures, such as infections or improper medication delivery.
Healthcare professionals who use these convenience kits for vascular or cardiac procedures are most at risk. Patients receiving treatments with these kits may also be affected due to potential contamination or injury from the syringes.
Check for kits with model numbers starting with K12T or K22C (e.g., K12T-01558G, K22C-00001). The specific lot numbers and UDI-DI codes listed in the recall document also indicate affected units.
Look for kits with model numbers starting with K12T or K22C (e.g., K12T-01558G, K22C-00001) as listed in the recall.
Reach out to Merit Medical Systems, Inc. to confirm if your specific kit is affected based on the model and lot numbers provided in the recall.
No, the FDA has identified these syringes as having leaks, breakage, and quality issues that could pose patient health risks. They are not safe for use.
Check if your kit has a model number starting with K12T or K22C as listed in the recall. Contact Merit Medical Systems, Inc. to confirm and get instructions.
Yes, the recall lists specific lot numbers and UDI-DI codes (e.g., 00884450352670) that are affected. Check your kit's documentation for these numbers.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2568-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2568-2024 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
