Events

Recall of Device Recall Circumcision trays and packs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deroyal Industries, Inc. Lafollette.

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
    59770
  • Event Risk Class
    Class 2
  • Event Number
    Z-3254-2011
  • Event Initiated Date
    2011-05-05
  • Event Date Posted
    2011-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103660
  • 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
    The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by surgical design.
  • Action
    DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.

Device

Device Recall Circumcision trays and packs
  • Model / Serial
    Lot Numbers: 20854003, 22892644, and 20012949
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
  • Product Description
    Circumcision trays and packs listed as follows: || (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic || Lot Numbers: 20854003, 22892644 || (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Number 20012949 || Circumcision Clamp
  • Manufacturer
    Deroyal Industries, Inc. Lafollette

Manufacturer

Deroyal Industries, Inc. Lafollette
  • Manufacturer Address
    Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA