Events

Recall of Device Recall QuikClot TraumaPad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Z-Medica, LLC.

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
    77316
  • Event Risk Class
    Class 2
  • Event Number
    Z-2612-2017
  • Event Initiated Date
    2017-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155692
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    Packaging breach may compromise sterility.
  • Action
    Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.

Device

Device Recall QuikClot TraumaPad
  • Model / Serial
    Lot # 7313
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
  • Product Description
    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable || hemostatic dressing || Part Number 460 || Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA || For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
  • Manufacturer
    Z-Medica, LLC

Manufacturer

Z-Medica, LLC
  • Manufacturer Address
    Z-Medica, LLC, 4 Fairfield Blvd, Wallingford CT 06492-1857
  • Manufacturer Parent Company (2017)
    Z-Medica Llc
  • Source
    USFDA