Device Recall Portex

Manufacturer

  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

117 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part Number 384001, 20 per case, Lot numbers: 551880804, 581451104, 581461104;  Part Number 386000, 15 per case, Lot numbers: 551890804, 600080205, 5518908004
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • Product Description
    Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
  • Manufacturer
  • Model / Serial
    Lot Numbers; 102151, 103108, 103218, K132627, K148054, K156266, K163449, K176543, K197127, K211492, K535999, K555552, K586403, K626840, K667012, K678478, K705482
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    4902 Glass L.O.R. Syringe
  • Manufacturer
  • Model / Serial
    Lot Numbers: 102517, K154089, K211495, K222113, K512485, K522220, K538711, K559480, K573554, K618300, K643592, K669735, K686834, K700785
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    4903 Glass L.O.R. Syringe
  • Manufacturer
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