Events

Recall of Applied Medical's LAP CHOLE KIT BLADED; Model Number: K0552

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Resources 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
    57702
  • Event Risk Class
    Class 2
  • Event Number
    Z-1510-2011
  • Event Initiated Date
    2010-09-10
  • Event Date Posted
    2011-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97041
  • 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
    Laparoscope, general &: plastic surgery - Product Code GCJ
  • Reason
    Applied medical is conducting a voluntary recall of specific lot numbers of the direct drive laparoscopic clip applier, model number ca090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
  • Action
    Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.

Device

Applied Medical's LAP CHOLE KIT BLADED; Model Number: K0552
  • Model / Serial
    LOT NUMBER(S): 1121587
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.
  • Product Description
    Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
    Applied Medical Corporation
  • Source
    USFDA