Events

Recall of Device Recall Ansell Sandel Weighted Safety Scalpel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ansell Sandel Medical Industries LLC.

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
    67005
  • Event Risk Class
    Class 2
  • Event Number
    Z-0639-2014
  • Event Initiated Date
    2013-11-12
  • Event Date Posted
    2014-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124495
  • 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
    Handle, scalpel - Product Code GDZ
  • Reason
    Select lots of sandel weighted safety scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
  • Action
    The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email sandel-cs@ansell.com. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email sandel-cs@ansell.com

Device

Device Recall Ansell Sandel Weighted Safety Scalpel
  • Model / Serial
    510 K exempt Device Listing Number D129456 Model Number 2215-N LN 1203 and 1553
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.
  • Product Description
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.
  • Manufacturer
    Ansell Sandel Medical Industries LLC

Manufacturer

Ansell Sandel Medical Industries LLC
  • Manufacturer Address
    Ansell Sandel Medical Industries LLC, 19736 Dearborn St, Chatsworth CA 91311-6509
  • Source
    USFDA