Device Recall Bard

  • Model / Serial
    Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units).  Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MA
  • Product Description
    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA

81 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers NGYJ0603 and NGYJ1671
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
  • Product Description
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
  • Manufacturer
  • Model / Serial
    Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
  • Product Description
    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. || The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
  • Manufacturer
  • Model / Serial
    The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to domestic and foreign conference attendees.
  • Product Description
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
  • Manufacturer
  • Model / Serial
    Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • Manufacturer
  • Model / Serial
    Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • Manufacturer
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