Events

Recall of Device Recall 500 mL InfoV.A.C. Canisters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by KCI USA, 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
    49110
  • Event Risk Class
    Class 2
  • Event Number
    Z-2439-2008
  • Event Initiated Date
    2008-07-29
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72779
  • 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
    Ac-Powered Suction Apparatus - Product Code JCX
  • Reason
    The port on the 500ml infov.A.C. canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
  • Action
    Urgent - Medical Device Recall letters were sent within the US on 07/29/08 via UPS next day delivery service and a return receipt was maintained to demonstrate delivery of the recall to all consignees. Additionally, firm is sending representatives into accounts which received more than three sales units of canisters and to all foreign consignee locations to facilitate quarantine and replacement of affected stock. Consignees asked to confirm that adequate flow is being delivered and that the dressing is being drawn down for those patients currently using the InfoV.A.C. Canisters. Also, consignees are to locate and quarantine all packaged 500 ml canisters without the green inspection stickers from within the affected lot numbers in their inventory. A KCI Rep will contact them to help facilitate this process. Consignees are to complete and return the Recall Acknowledgement and Inventory Accounting Form. KCI will replace any affected product at their facility and arrange for the return of any affected product.

Device

Device Recall 500 mL InfoV.A.C. Canisters
  • Model / Serial
    For M8275063/5: 20064392, 20069119, 20069125, 20069126, 20069279, 20069279.18308F, 20075082, and 20079173  For M8275063/10: 20046268, 20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753, 20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303, 20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274, 20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A, 20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265, 20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178, 20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186, 20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749, 20089750, 20093372, 20093374, and 20094200
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.
  • Product Description
    500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Manufacturer Address
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA