Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical Production Co. Ltd. that may leak or break, posing health risks. Check your product model numbers to see if affected.
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 is recalling convenience kits that contain syringes made by Jiangsu Shenli Medical Production Co. Ltd. These syringes have been identified by the FDA as potentially leaking, breaking, or having other quality issues that could harm patients. Affected kits include specific model numbers listed in the recall.
The syringes in these kits have been identified by the FDA as having leaks, breakage, or other quality issues. These problems could lead to patient health risks if the syringes are used improperly or if they fail during medical procedures.
Patients using these medical convenience kits for procedures like angiography or angioplasty are at risk if they have the recalled syringes. The risk is primarily for those who use the kits for medical procedures.
Check if your kit includes model numbers starting with K09T or K12T followed by specific numbers listed in the recall. The kits are used for vascular or cardiac procedures and contain syringes from Jiangsu Shenli Medical Production Co. Ltd.
Look for model numbers starting with K09T or K12T followed by specific numbers listed in the recall (e.g., K09T-01138, K12T-02061A).
The FDA has identified these syringes as having leaks, breakage, or quality issues that could pose health risks. They are not safe for use.
Check if your kit has model numbers starting with K09T or K12T followed by specific numbers listed in the recall (e.g., K09T-01138, K12T-02061A).
The recall does not specify a remedy, so you should contact Merit Medical directly to get advice on next steps.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2578-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2578-2024 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.
