Merit Medical recalls convenience kits with Jiangsu Shenli Medical syringes due to leaks and breakage risks. Affected kits may pose patient health hazards.
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 include syringes made by Jiangsu Shenli Medical. These syringes have been identified as leaking or breaking, which could harm patients.
The syringes in the kits can leak or break during use, potentially causing injury or infection to patients. This risk is especially concerning during medical procedures that require precise handling.
Patients using these convenience kits for medical procedures are at risk. Healthcare providers who use the kits for catheter introductions may also be affected.
Check for kits labeled with SafeSheath CSG (Introducer Catheter) and reference numbers FCL-069-00/A, FCL-069-02/A, or FCL-069-03/A. The kits were sold with specific lot numbers and UDI-DI codes listed in the recall notice.
Look for SafeSheath CSG (Introducer Catheter) labels with reference numbers FCL-069-00/A, FCL-069-02/A, or FCL-069-03/A.
Reach out to Merit Medical for guidance on next steps if you have the affected kits.
The syringes can leak or break during use, which may cause patient injury or infection.
Check for kits labeled SafeSheath CSG (Introducer Catheter) with reference numbers FCL-069-00/A, FCL-069-02/A, or FCL-069-03/A.
Contact Merit Medical for guidance on next steps if you have the affected kits.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2571-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2571-2024 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.
