Device Recall 4Way TPiece

  • Model / Serial
    Catalog No.: 395945, Lot numbers: 116040, 116039, 114795, 113887, 113886, 113232, 113230, 113095, 113027, 119110, 118134, 119988, 119989, 129179, 128393, 128028, 126119, 126118, 124951, 123197, 123198, 122461, 122033, 131793, 120731;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    4-Way Tee with 2 one-way valves, Ref 395945 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