Events

Recall of Device Recall DeRoyal ST. Circumcision Clamp, REF 321622, Size 1.3 cm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal 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
    67442
  • Event Risk Class
    Class 2
  • Event Number
    Z-1134-2014
  • Event Initiated Date
    2014-01-16
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125456
  • 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
    Clamp, circumcision - Product Code HFX
  • Reason
    Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
  • Action
    DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible.

Device

Device Recall DeRoyal ST. Circumcision Clamp, REF 321622, Size 1.3 cm
  • Model / Serial
    lot numbers 33347799, 33444071, and 33423747
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
  • Product Description
    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA