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Moderate riskFDA DeviceClass II

Merit Medical Custom Waste Management Kit Vascular Tray recalled for detaching inflation device handle

Merit Medical Systems is recalling specific lots of their Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt patient care. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

  1. If you use this product, stop using affected lot numbers immediately: T2736369, T2781930, T2898771S, T3047503, T3090431, T3121937, T3146114, T3158708, T3204129, T3232415
  2. Contact Merit Medical Systems or your supplier for instructions on returning or replacing the product
  3. Review your records to identify affected units in your facility
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
864 units
Illnesses reported
None reported
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Classification
Class II
Recall number
Z-1125-2026

In the FDA's words

Description
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 Inflation device handle may detach from the syringe during procedure. UDI: 00884450320297/ Lot: T2736369 T2781930 T2898771S T3047503 T3090431 T3121937 T3146114 T3158708 T3204129 T3232415 Distribution: 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. Affected quantity: 864 units
Hazard
Inflation device handle may detach from the syringe during procedure.

7 products in this recall

Merit Medical inflation devices and kits recalled for handle detachment

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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