basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling the basixALPHA Inflation Device (30 atm/bar 20 mL) due to a design issue that can cause the inflation syringe handle to separate from the inflation device when the handle is withdrawn. This device is used to inflate and deflate angioplasty balloons and other interventional devices, as well as to measure pressure. The recall affects 7,211 devices that were distributed worldwide and throughout numerous U.S. states, as well as in multiple countries including Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, New Zealand, Norway, Spain, and others.
The recalled devices are identified by specific catalog numbers (IN3130, IN3152, IN3302, and IN3802) and associated lot numbers. Affected consumers should contact Merit Medical Systems, Inc. directly for guidance, as the recall documentation does not specify a remedy or instructions for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Reason for recall: Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Swe Quantity: 7,211 devices Lot/code info: Catalog Number: IN3130 UDI: 00884450440179; 00884450510155; Lot Numbers: H1862928; H1896261; H1923761; H1929106; H1939255; H1966485; H1978295; H2068264; H2073193; H2073247; H2077173; Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262; H1909581; H1923762; H1929107; H1978299; H2007415; H2031599; H2068265; H2073248; H2077175; H2084368; Catalog Number: IN3302 UDI: 00884450511305 Lot Numbers: H1896263; H1966489; Catalog Number: IN3802 UDI: 00884450511510 Lot Numbers: H18962650; H1939259; H1966490; H1973390; H1978305; H1993118; H2001426; H2007417; H2012534; H2031601; H2073198; H2073249; H2077176;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.