Device Recall Power PORTACATH

  • Model / Serial
    a. Item No. 21-4474-24 (Lot No. 87X040, 87X117);  b. Item No. 21-4475-24 (Lot No. 87X044);  c. Item No. 21-4477-24 (Lot No. 87X097);  d. Item No. 21-8466-24 (Lot No. 87X171);  e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180);  f. Item No. 21-8469-24 (Lot No. 87X151);  g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
  • Product Description
    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: || a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); || d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); || e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); || f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); || g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
  • Source
    USFDA