Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2564-2024 — Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J

U.S. FDA — Device Enforcement · United States · 2024-06-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2564-2024
Date of alert
2024-06-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merit Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884450410110
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.