Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes K04 models that may leak or break, risking patient health. Affected kits include specific catalog numbers and lot numbers.
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 as leaking or breaking, which could pose a risk to patient health. Consumers should check if their kit matches the listed catalog numbers or lot numbers to determine if it's affected.
The syringes in these kits may leak or break during use, potentially causing harm to patients. This issue was identified through a FDA safety alert from March 19, 2024, which noted quality problems with the syringes.
Users of medical convenience kits containing the specific syringe models (K04) with listed catalog numbers and lot numbers are affected. Healthcare professionals and patients using these kits for vascular or cardiac procedures are most at risk.
Check if your kit includes catalog numbers like K05-00203M, K05-00511J, or other listed K04 models. Look for lot numbers such as H2629466 or H2645484 on the syringes.
Identify your kit's catalog number and lot numbers to see if they match the affected list provided in the recall notice.
The affected syringes are K04 models from Jiangsu Shenli Medical Production Co. Ltd., with specific catalog numbers and lot numbers listed in the recall notice.
Check your kit's catalog number against the list of affected K04 models (e.g., K05-00203M) and lot numbers (e.g., H2629466) provided in the recall notice.
The recall notice does not specify a remedy, so you should check with Merit Medical directly for further instructions.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2562-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2562-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
