Events

Recall of Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merz Aesthetics, 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
    60851
  • Event Risk Class
    Class 3
  • Event Number
    Z-0694-2012
  • Event Initiated Date
    2011-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Merz aesthetics is initiating a medical device recall on tsk closed tip cannula (27ga x 25mm) due to a labeling error on the secondary (outer) packaging. the outer package label states that the carton contains cannulas that are 27ga x 25 mm in size instead of 27g x 38 mm. length of the cannula is a matter of user preference and is unlikely to impact patient safety.
  • Action
    Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You may contact Merz Aesthetics Customer Service at (866) 862-1211 or (262) 835- 3333 ,for instructions regarding the return and immediate replacement of the product, or if you have any further questions or concerns..

Device

Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, D...
  • Model / Serial
    Lot #1029402
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CA, NY, OK, and TN.
  • Product Description
    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. || The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
  • Manufacturer
    Merz Aesthetics, Inc.

Manufacturer

Merz Aesthetics, Inc.
  • Manufacturer Address
    Merz Aesthetics, Inc., 4133 Courtney Rd Ste 10, Franksville WI 53126-9127
  • Manufacturer Parent Company (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA