Device Recall RFMD TPiece

  • Model / Serial
    Catalog No. 395940, Lot numbers: 108273, 109600, 111314, 111229, 113984, 113932, 113931, 112991, 112514, 111588, 111589, 111558, 111557, 117867, 117866, 116471, 116163, 115616, 114992, 116865, 118714, 118055, 118054, 118053, 119421, 120628, 120521, 120021,120741, 120742, 122619, 122621, 122620, 123017, 123016, 123837, 126217, 125471, 125117, 124069, 126626, 126625, 127052, 127051, 128481, 128322, 127549, 127550, 129360, 129109, 129991, 130186, 130187.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Rusch Inc, 2450 Meadowbrook Pkwy, Duluth GA 30096-4635
  • Source
    USFDA