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