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Merit Medical Systems, Inc.: Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Medical DevicesSource: FDA (device) · Date: 2026-01-28

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Merit Medical Systems, Inc.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Reason / hazard
Inflation device handle may detach from the syringe during procedure.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
Recall initiated
2025-12-04
Code info
UDI: 00884450320297/ Lot: T2736369 T2781930 T2898771S T3047503 T3090431 T3121937 T3146114 T3158708 T3204129 T3232415
Product quantity
864 units
Voluntary mandated
Voluntary: Firm initiated
City
South Jordan
State
UT
Country
United States
Event id
98139
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