Events

Recall of Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook¿ ***

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Endoscopy.

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
    35265
  • Event Risk Class
    Class 3
  • Event Number
    Z-0848-06
  • Event Initiated Date
    2006-04-20
  • Event Date Posted
    2006-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45689
  • 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
    unknown device name - Product Code KOG
  • Reason
    Large product label contains an incorrect expiration date.
  • Action
    Consignees were notified by letter (USPS certified)on/about April 21, 2006.

Device

Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supp...
  • Model / Serial
    Lot: W2110292, Correct expiration on Small OEM Label: Mar-08, Expiration date on Large Label Apr-08;  W2118663, Correct exp.: Mar-08, Exp. On large label: Apr-08;  W2126166, Correct exp.: Apr-08, Exp. On large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label: May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018, Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.: Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label: May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318, Correct exp.: Sep-08, Exp. On large label: Oct-08.
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Alabama consignees
  • Product Description
    Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook¿ *** || Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook¿ * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
  • Manufacturer
    Cook Endoscopy

Manufacturer

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