Events

Recall of Device Recall Prostate Seeding Needle for Use with the Mick Applicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Manan Medical Products, 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
    31963
  • Event Risk Class
    Class 3
  • Event Number
    Z-0922-05
  • Event Initiated Date
    2005-05-03
  • Event Date Posted
    2005-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38818
  • 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
    Source, Brachytherapy, Radionuclide - Product Code KXK
  • Reason
    The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
  • Action
    Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.

Device

Device Recall Prostate Seeding Needle for Use with the Mick Applicator
  • Model / Serial
    Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Florida and Georgia
  • Product Description
    Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: || a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090
  • Manufacturer
    Manan Medical Products, Inc.

Manufacturer

Manan Medical Products, Inc.
  • Manufacturer Address
    Manan Medical Products, Inc., 241 W Palatine Rd, Wheeling IL 60090-5824
  • Source
    USFDA