Events

Recall of Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    46792
  • Event Risk Class
    Class 2
  • Event Number
    Z-1453-2008
  • Event Initiated Date
    2008-01-31
  • Event Date Posted
    2008-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69110
  • 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
    Wound Drainage Device Infection Control Kits - Product Code GCY
  • Reason
    Leakage: the kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
  • Action
    Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.

Device

Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits
  • Model / Serial
    Lot Numbers; 60004885, 60018681, 60030745, 60045264, 60056512, 60090134, 60101563, 60124258, 60152076, 60189147, 60192877, 60198414, 60217797, 60236478, 60255679, 60281660, 60314033, 60377257, 60402970, 60406391, 60419371, 60444465, 60463238, 60479892, 60511109, 60554807, 60575194, 60586769, 60607929 and 60621372.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Product Description
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-702-10; 400 ml INF. CNTRL. Kit W/ 1/8" Drain Spec., 3.2mm, 10Fr., PVC, 107cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA