Events

Recall of Device Recall Presource Custom Sterile Surgical and Procedure Kits

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

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
    60845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0925-2012
  • Event Initiated Date
    2011-12-23
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106635
  • 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
    The presource kits were assembled with a jobri infant restraint strap which does not have the appropriate 510(k) pre-market clearance.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 23, 2011 to the affected hospital consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected component upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit/replacement the consignees were instructed to contact the folowing: Hospitals - Presource Sales Operations at 800-766-0706; Federal Government facilities - Government Customer Service at 800-444-1166; and Distributors - Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Device

Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.
  • Product Description
    Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; || The kit catalog numbers listed in the code information section below contain one or more of the following listed components: || a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; || b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; || The restraint is used to secure an infant during a circumcision procedure. || Product Usage: || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA