Merit Medical Systems, Inc.: Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

Hazard

Inflation device handle may detach from the syringe during procedure.

Details from the source

Reason for recall: Inflation device handle may detach from the syringe during procedure. 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, Br Lot/code info: Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055

UPC codes

00884450389683, 00884450264003, 00884450481660

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.