Events

Recall of Device Recall Mermaid Medical MBiopsy Coaxial Introducer Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mermaid Medical A/S.

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
    71525
  • Event Risk Class
    Class 2
  • Event Number
    Z-2190-2015
  • Event Initiated Date
    2015-06-15
  • Event Date Posted
    2015-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138105
  • 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, biopsy, cardiovascular - Product Code DWO
  • Reason
    Mermaid medical a/s is recalling some of their m-biopsy coaxial introducer needles because of the potential for small plastic pieces to be present in the luer of the cannula.
  • Action
    The firm, Mermaid Medical, notified both customers directly via email with written letters dated June 12 and June 15, 2015 followed up by sales and customer service for product return to MMI. The customers were instructed to "Please coordinate the return of the mentioned products with corresponding lot numbers with our Mermaid Medical's Customer Care the recalled product: either by phone at 1{720}420-9999 or by email: customercare@mermaidmedical.com". If you have any questions please do not hesitate to contact Vice President QA & Regulatory Affairs toll free at (855) 427-6799 or (720) 420-9999 or email: customercare@memaidmedical.com.

Device

Device Recall Mermaid Medical MBiopsy Coaxial Introducer Needle
  • Model / Serial
    Lot No: P000290, P000360, P000230, P000291, P000299, P000148 Catalogue No: N20314010- N20320020 (for PRO-MAG Biopsy Instrument) Catalogue No: N20414010- N20420020 (for MAGNUM Biopsy Instrument)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to FL including PR.
  • Product Description
    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a || white carton unit box. || The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
  • Manufacturer
    Mermaid Medical A/S

Manufacturer

Mermaid Medical A/S
  • Manufacturer Address
    Mermaid Medical A/S, Frydensbergvej 25, Stenl?se Denmark
  • Manufacturer Parent Company (2017)
    Mermaid Medical A/S
  • Source
    USFDA