Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347 Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035 Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967 Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merit Medical Systems, Inc.
- Reason for 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Product Codes/Lot Numbers:
Catalog Number: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347 Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035 Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967 Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2563-2024
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