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Various Merit Medical convenience kits that contain… recallZ-2560-2024 · Merit Medical Systems, Inc. · initiated Jun 11, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: No Marketing Application

What the company is doing

On 06/11/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" Letter to customers informing them that specific Merit Medical convenience kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes lack the appropriate/sufficient FDA market authorization. In addition, Merit Medical posted the Urgent Medical Device Recall letter and complete list of affected products/kits on their website at https://www.merit.com/products/documents/product-notices/. Customer are instructed to: 1. Immediately determine if any of the products identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that appropriate personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4. Follow the attached instructions for placing the recall labels on the products containing Jiangsu Shenli syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact Customer Service at (801) 208-4381. Product may be returned to inventory once properly over-labeled. 5.At the point of use, the Jiangsu Shenli syringes are to be discarded. Photographs of Jiangsu Shenli syringes are enclosed to assist in identification. 6.Post this URGENT MEDICAL DEVICE RECALL NOTICE and Jiangsu Shenli Syringe photographs on or near the affected products. 7.If replacement syringes are needed, contact Customer Service at (801) 208-4381 for recommended syringe suppliers. For questions contact Merit Sales Representative or Merit Customer Service at 801-208-4381, Hours: 6 am to 6 pm MST Mon.-Fri.

Recall details

Recall number
Z-2560-2024
Status
Open, Classified
Initiated by the company
Jun 11, 2024
Posted by the FDA
Aug 12, 2024
Recalling firm
Merit Medical Systems, Inc.
Quantity
3,647 kits
Product code
OEQ
Distribution
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Product description

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.

Code information (models, lots, serial numbers)

Catalog Number: K02-00873A UDI-DI code: 00884450156261 Lot Numbers: H2597212 H2620955 H2641148 Catalog Number: K02-01105A UDI-DI code: 00884450156124 H2486384 H2542259 H2628908 Catalog Number: K02-01481A UDI-DI code: 00884450164464 H2387157 H2418377 H2472043 H2486729 H2507912 H2517550 H2526240 H2552843 H2595093 H2628968 H2655130 H2678790 H2699921 H2712471 H2747868 H2822453 H2831126 H2846806 H2868403 H2884580 H2897149 H2916452

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94797).

Sources and updates

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