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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Merit Medical Systems, Inc.: Medical Convenience Kits Recalled Due to Defective Plastic Syringes

Agency Publication Date: August 12, 2024
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Summary

Approximately 2.89 million Merit Medical convenience kits, including procedure trays for angiography, waste management, and fluid management, are being recalled. These kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that have been identified as having quality issues such as leaks and breakage. Consumers and healthcare providers should identify if they have affected kits and contact Merit Medical for guidance, as no specific repair or replacement remedy was provided in the initial notice.

Risk

Defective syringes in these kits can leak or break during use, which may lead to incorrect medication dosing, procedure delays, or air bubbles entering a patient's bloodstream. These issues pose a moderate risk to patient health depending on the medical procedure being performed.

What You Should Do

  1. Check your medical inventory for any Merit Medical convenience kits, specifically identifying models such as the Rapid Response Waste Management System, Custom Procedure Kits, Outake Catheter Extractors, and Prelude SNAP kits.
  2. Compare the Catalog Numbers and Lot Numbers on your product packaging against the extensive list of affected codes, including lot numbers starting with 'T' (e.g., T2581281) and 'H' (e.g., H2597212).
  3. If your kit is confirmed to be part of this recall, do not use the syringes contained within it and contact your healthcare provider for further medical instructions.
  4. Contact Merit Medical Systems, Inc. directly for guidance on returning or disposing of the affected kits and to discuss potential replacement options.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Consultation

How to: Contact your healthcare provider or the manufacturer (Merit Medical Systems, Inc.) for further instructions regarding the affected convenience kits.

Affected Products

Product: Rapid Response Waste Management System Kit
Model / REF:
BRC-BAL-INT-SL/B
UPC Codes:
00884450363102
Lot Numbers:
T2581281
T2594451
T2606225
T2609782
T2628321
T2643945
T2685079
T2712303
T2745782
T2758208
T2800973
T2805964
T2846532
T2846539
T2850757
T2901641
Product: Custom Procedure Kit (Angiography/angioplasty kit)
Model / REF:
K12T-10773
K12T-09284D
K12T-10621
K12T-10800
K12T-12491
UPC Codes:
00884450426388
00884450602102
00884450409435
00884450421093
00884450820605
Lot Numbers:
T2800379
T2824129
T2849013
T2857243
T2209872
T2220946
T2359067
T2364198
T2508160
T2674429
T2794927
T2800155
T2308653
T2344516
T2411888
T2428905
T2429939
T2448507
T2452908
T2473123
T2498967
T2531706
T2597113
T2611405
T2629759
T2653268
T2685014
T2691082
T2715028
T2744136
T2776727
T2846077
T2873111
T2280633
T2407018
T2503204
T2643484
T2680463
T2705035
T2885158
T2905902
Product: Outake Catheter Extractor Kit
Model / REF:
CET200
CET300
UPC Codes:
00884450052587
00884450045497
Lot Numbers:
T2651502
T2700122
T2712304
T2748973
T2758209
T2779867
T2833064
T2850758
T2903817
T2626011
T2662043
T2701699
T2726893
T2750399
T2758210
T2805965
T2832137
T2849258
T2886083
T2921078
Product: K02 Custom Syringe Kit
Model / REF:
K02-00873A
K02-01105A
K02-01481A
UPC Codes:
00884450156261
00884450156124
00884450164464
Lot Numbers:
H2597212
H2620955
H2641148
H2486384
H2542259
H2628908
H2387157
H2418377
H2472043
H2486729
H2507912
H2517550
H2526240
H2552843
H2595093
H2628968
H2655130
H2678790
H2699921
H2712471
H2747868
H2822453
H2831126
H2846806
H2868403
H2884580
H2897149
H2916452
Product: K04 Custom Syringe Kit
Model / REF:
K04-00791A
UPC Codes:
00884450148471
Lot Numbers:
H2387533
H2408714
H2423858
H2447173
H2484854
H2509065
H2547204
H2557351
H2640509
H2669424
H2704230
H2770492
H2780739
H2792326
H2864128
H2869756
H2916432
Product: Prelude SNAP Introducer Catheter Kit
Model / REF:
PLS-1006/A
PLS-1007/A
PLS-1008/A
PLS-1009.5/A
PLS-1009/A
PLS-1010.5/A
PLS-1010/A
PLS-1011/A
PLS-2506/A
PLS-2508/A
PLS-2509/A
PLS-2510/A
PLS-2511/A
PLSX-1006/A
PLSX-1007/A
PLSX-1008/A
PLSX-1009/A
UPC Codes:
00884450467954
00884450467985
00884450467992
00884450468036
00884450468012
00884450468050
00884450468043
00884450468067
00884450468098
00884450468111
00884450468128
00884450468135
00884450468159
00884450489550
00884450489567
00884450489574
00884450489598
Lot Numbers (65):
I2868407
I2873488
I2884101
I2889284
I2889285
I2889286
I2889287
I2889289
I2889288
I2903937
I2903938
I2903939
I2914399
I2925168
I2925169
I2790541
I2862963
I2868410
I2868412
I2873489
I2882475
I2868415
I2884088
I2889299
I2889300
I2661407S1
I2661408S1
I2925190
I2862967
I2873494
I2889301
I2925173
I2790564
I2873496
I2884103
I2889303
I2889306
I2862970
I2873497
I2873498
I2873499
I2873500
I2889327
I2889329
I2873501
I2889331
I2914419
I2889334
I2687649S1
I2868417
Product: Safety Paracentesis Procedure Tray Kit
Model / REF:
SPPT-100/D
SPPT-5F-10/D
SPPT-5F-10L/B
SPPT-5F-10S
SPPT-5F-12PL
SPPT-5F-17PL
SPPT-5F-7/D
SPPT-5F-7L/B
SPPT-5F-7S
SPPT-6F-10L
SPPT-6F-10S
SPPT-6F-12PL
SPPT-6F-12PS
SPPT-6F-17PL
SPPT-8F-10L
SPPT-8F-12PL
TAPS-100
TAPS-5F-10LT
TAPS-5F-10T
TAPS-5F-12PLT
TAPS-5F-17PLT
TAPS-5F-7LT
TAPS-5F-7T
TAPS-6F-10LT
UPC Codes:
00884450038659
00884450038673
00884450038680
00884450038697
00884450038703
00884450038710
00884450038727
00884450038734
00884450038741
00884450038758
00884450038765
00884450038772
Lot Numbers:
T2382100
T2382102
T2748984
T2871502
T2666406
T2762926
T2351182
T2379511
T2385424
T2801601
T2351188
T2365762
T2379520
T2680782
T2351191
T2379524
T2581126
T2319777
T2368460
T2385066
T2351200
T2365767
T2384431
T2928291
T2719257
T2389562
T2704428
T2438157
T2340050
T2867197
T2379537
T2489939
T2477572
T2489947
T2570343
T2503569
T2503571
T2543035

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94797
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 23 products (2388 kits; 11837 kits; 3631 kits; 3,647 kits; 1,390 kits; 13,560 kits; 3,694 kits; 188837 kits; 138471; 69 kits; 34197 kits; 103369 kits; 72115 kit; 7442 kits; 900 kits; 30 kits; 5700 kits; 55305; 745 kits; 317115 kits; 4027 kits; 168157 kits; 1,753,625 kits)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.