Events

Recall of Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deroyal Surgical -Rose Hill.

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
    30045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1490-04
  • Event Initiated Date
    2004-09-09
  • Event Date Posted
    2004-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35068
  • 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
    Drape, Surgical - Product Code KKX
  • Reason
    Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
  • Action
    The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.

Device

Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; ...
  • Model / Serial
    Lot # 1007298  1007335  1007360  1030228  1030244  1045526  1049113  1081519  1107441  1141972  1161316  1161332  1200979  1225252  1306538  1310369  1315021  1330597  1330600  1342811  1375681  1375808  1375816  1490540  1504008  1504032  1521713  1543630  1571438  1650988  1736028  1759511  1802072  1911543  1911615  2076658  2076738  2137810  2137828  2138062  2187067  2228121  2376204  2701345  765821  765855  804316  805431  805440  825580  825598  825635  825643  850507  900691  932991  933071  933097  933118  933151  950663  950680  950743  974585  974593  974665
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
  • Product Description
    Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
  • Manufacturer
    Deroyal Surgical -Rose Hill

Manufacturer

Deroyal Surgical -Rose Hill
  • Manufacturer Address
    Deroyal Surgical -Rose Hill, 100 Rose Hill Industrial Park, Rose Hill VA 24281
  • Source
    USFDA