Events

Recall of STERILE SAMPLE CATH LAB PACK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries, 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
    66080
  • Event Risk Class
    Class 1
  • Event Number
    Z-1053-2014
  • Event Initiated Date
    2013-08-14
  • Event Date Posted
    2014-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121476
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    Guidewire .035x150 3mmj tcfc, item number 88241, has a potential for the coating to flake off of the wire. the guidewire is used in a number of surgical convenience kits assembled and marketed by medline industries, inc.
  • Action
    The firm, Medline Industries, Inc., sent a "RECALL IMMEDIATE ACTION REQUIRED" letter dated August 14, 2013, to its direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their stocks for inventory of the affected products, quarantine any affected products, return the product using the enclosed shipping slips for credit-If additional stickers are needed, please call 866-359-1704, and complete and return the enclosed FAX-BACK VERIFICATION FORM listing the quantity of affected product(s) on hand via fax to Medline at 866-767-1290. If you have any questions, please contact 866-359-1704.

Device

STERILE SAMPLE CATH LAB PACK
  • Model / Serial
    Pack Number: SAMP0213;  Lot: 13CD1774
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
  • Product Description
    STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com || Surgical kit used to supply tools required to perform medical procedures.
  • Manufacturer
    Medline Industries, Inc.

Manufacturer

Medline Industries, Inc.
  • Manufacturer Address
    Medline Industries, Inc., 1170 S Northpoint Blvd, Waukegan IL 60085-6757
  • Source
    USFDA