Device Recall BD

  • Modèle / numéro de série
    Catalog #303348, Lot #4209518  Catalog #305064, Lot #4205576  Catalog #309644 Lot #4209524
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, || BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 || BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 || Product Usage: || 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. || 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: || -Accessing pre-slit/pre-pierced IV septum ports || -Providing for fluid transfer || -Can be used as tubing adapter || 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
  • Source
    USFDA

145 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Lot number 4220622, Expiry 2016-04-30.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
  • Description du dispositif
    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. || Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
  • Manufacturer
  • Modèle / numéro de série
    Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
  • Description du dispositif
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
  • Manufacturer
  • Modèle / numéro de série
    Lot #'s 4128925 and 4128926
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
  • Description du dispositif
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. || An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
  • Manufacturer
  • Modèle / numéro de série
    Serial Nos. E34297300656, E34297300657, E34297300659, E34297300660, E34297300661, E34297300666, E34297300667, E34297300668, E34297300669, E34297300670, E34297300671, E34297300673, E34297300675, E34297300676, E34297300677, E34297300678  E34297502563, E34297502564, E34297502565, E34297502566, E34297502567, E34297502568, E34297502569, E34297502570, E34297502571, E34297502572, E34297502573, E34297502574, E34297502575, E34297502576, E34297502577, E34297502578, E34297502579, E34297502580, E34297502581, E34297502583, E34297502584, E34297502585, E34297502586, E34297502587, E34297502588, E34297502589, E34297502590, E34297502591, E34297502592, E34297502593, E34297502594, E34297502595, E34297502596, E34297502597, E34297502599, E34297502600, E34297502601, E34297502602, E34297502603, E34297502604, E34297502605, E34297502606, E34297502607, E34297502608, E34297502612, E34297502613, E34297502619, E34297502620, E34297502621, E34297502629, E34297600499, E34297600501, E34297600502, E34297600503, E34297600507, E34297600508.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
  • Description du dispositif
    BD FACSCalibur; || Catalog Numbers 342973, 342975, 34976 || In vitro Diagnostics Use.
  • Manufacturer
  • Modèle / numéro de série
    Lot 5008762, Exp 11/30/16.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in states of: MO, GA, AZ, NE, TX, VA
  • Description du dispositif
    CD123 (9F5) PE || Catalog number 649453 || Analyte Specific Reagent
  • Manufacturer
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