Events

Recall of Device Recall BardParker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aspen Surgical Puerto Rico Corp..

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
    74584
  • Event Risk Class
    Class 2
  • Event Number
    Z-2755-2016
  • Event Initiated Date
    2016-06-27
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147986
  • 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
    Blade, scalpel - Product Code GES
  • Reason
    After receiving a complaint the firm disclosed that conventional stainless steel surgical blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12b.
  • Action
    An "Urgent: Medical Device Correction" letter was sent on June 27, 2016. The letter provided background on the issue, as well as actions to be taken by the user. Customers have the alternative to either keep the product or return it for replacement. A response form was included for customers to complete and return. Customers are to maintain awareness of the incorrect identification prior to use. Questions concerning the correction can be directed to Pedro.Garcia@WelchAllyn.Com.

Device

Device Recall BardParker
  • Model / Serial
    LOT 0088464
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution only.
  • Product Description
    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." || Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
  • Manufacturer
    Aspen Surgical Puerto Rico Corp.

Manufacturer

Aspen Surgical Puerto Rico Corp.
  • Manufacturer Address
    Aspen Surgical Puerto Rico Corp., Rd 183 Km 20.3, Las Piedras PR 00771
  • Source
    USFDA