Events

Recall of AcuSnare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wilson-Cook Medical 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
    28903
  • Event Risk Class
    Class 3
  • Event Number
    Z-0906-04
  • Event Initiated Date
    2004-04-21
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32747
  • 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
    Snare, Flexible - Product Code FDI
  • Reason
    The snares inside the box labeled sasm-1 may actually be asm-1 devices. the individual pouches may be correctly labeled asm.
  • Action
    Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.

Device

AcuSnare
  • Model / Serial
    Reorder (Catalog) number: ASM-1, Lot#W1834120 and Reorder (Catalog) number: SASM-1, Lot#W1834310
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, NY, OK
  • Product Description
    AcuSnare¿ Polypectomy Device, Cook¿ Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • Manufacturer Address
    Wilson-Cook Medical Inc, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA