Events

Recall of Device Recall HSG Procedure Tray 7Fr

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Device Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57585
  • Event Risk Class
    Class 2
  • Event Number
    Z-0215-2012
  • Event Initiated Date
    2010-12-22
  • Event Date Posted
    2011-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96709
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter care tray (kit) - Product Code OHR
  • Reason
    Medical device technologies, inc. dba angiotech, is recalling hsg procedure trays and bone biopsy trays distributed between december 2007 and december 14, 2010 for package integrity.
  • Action
    The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.

Device

Device Recall HSG Procedure Tray 7Fr
  • Model / Serial
    Catalog # 660007000 Lot Number(s): 81781ODR; 82041OSH; 82741Q2H; 82871QBF; 83101QRH; 83431RC7; 90151RYF; 90471SME; 90681T3F; 91131TZL; 91461UMC; 92251W8Z; 92521WOC; 92861XCL; 92941XJ6; 93421YAU; 00531ZJM; 010320FR; 011020JE; 016121GL; 02102297; 0260231B.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • Product Description
    Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (7Fr); 1 - Fixed Volume Syringe - 3cc; 1 - CSR Wrap***Catalog Number: 660007000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com. || HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Manufacturer Address
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Manufacturer Parent Company (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA