Merit Medical Systems, Inc.: Merit Medical , Custom Manifold Kit REF: K09-13203A

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 Quantity: 2192 units Lot/code info: K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407

UPC codes

00884450479964

Source

Official record: FDA (Device enforcement) ↗

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