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Prelude SNAP recallZ-2574-2024 · 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-2574-2024
Status
Open, Classified
Initiated by the company
Jun 11, 2024
Posted by the FDA
Aug 12, 2024
Recalling firm
Merit Medical Systems, Inc.
Quantity
55305
Product code
DYB
FDA submissions
K143255
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: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Catalog Number/UDI-DI code/Lot Numbers: PLS-1006/A 00884450467954 I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A 00884450467985 I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A 00884450467992 I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A 00884450468036 I2862967 I2873494 I2889301 I2925173 PLS-1009/A 00884450468012 I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A 00884450468050 I2862970 PLS-1010/A 00884450468043 I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A 00884450468067 I2889329 PLS-2506/A 00884450468098 I2873501 I2889331 I2914419 PLS-2508/A 00884450468111 I2889334 PLS-2509/A 00884450468128 I2687649S1 I2868417 I2914426 PLS-2510/A 00884450468135 I2873503 I2889336 PLS-2511/A 00884450468159 I2889337 PLSX-1006/A 00884450489550 I2868420 I2873516 I2889355 I2914466 PLSX-1007/A 00884450489567 I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A 00884450489574 I2889357 PLSX-1009/A 00884450489598 I2914468

Devices named in this recall

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

Product lines

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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