Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating

  • Model / Serial
    Lots 1ML0052506, 1ML0062201, 1ML0080901
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AZ, CA, CO, FL, IL, KS, MI, MO, NC, NJ, NY, OH, OK, PA, PR and country of: South Africa.
  • Product Description
    Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 || --- The Exodus Drainage Catheter consists of a radiopaque || polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. || Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lots 1ML0060705, 1ML0070901, 1PD0040501
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AZ, CA, CO, FL, IL, KS, MI, MO, NC, NJ, NY, OH, OK, PA, PR and country of: South Africa.
  • Product Description
    Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. || Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
  • Manufacturer