Events

Recall of Device Recall Cardinal Health Gomco Style Circumcision Clamp Trays

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
    73497
  • Event Risk Class
    Class 2
  • Event Number
    Z-1320-2016
  • Event Initiated Date
    2016-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144307
  • 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
    Circumcision tray - Product Code OHG
  • Reason
    Two lots of gomco style circumcision clamp trays, ssi-0034 and 10-1100 contained a 1.3cm circumcision clamp. they both were labelled as containing a 1.1cm clamp.
  • Action
    Cardinal Health sent an URGENT: PRODUCT RECALL letter dated February 29, 2016, to affected consignees explaining the reason for the product recall and actions that should be taken by the end user. These included the following actions: 1. STOP using affected product. 2. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 3. NOTIFY any customers to whom you may have distributed product affected by this recall. 4. CONTACT the appropriate Customer Service group to arrange for return of any affected product you may have: " Hospital800.964.5227 " Distributor800.635.6021 The firm asks that consignees who have question or requests of special assistance relating to the recall should contact Cardinal Health Customer Advocacy at 800.292.9332. For questions regarding this recall call 847-473-1500.

Device

Device Recall Cardinal Health Gomco Style Circumcision Clamp Trays
  • Model / Serial
    SSI-0034 with LOT# 462799 & 476803  10-1100 with LOT# 462788 & 485406
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
  • Product Description
    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
  • 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