Events

Recall of Medline Latex Free Vaginal Delivery CDSLF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    49107
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2009
  • Event Initiated Date
    2008-08-04
  • Event Date Posted
    2008-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73460
  • 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
    Cesarean Section Kit - Product Code OHM
  • Reason
    The latex free labor & delivery packs contain a latex nuk pacifier. the pacifier is packaged separately and offers no risk of exposure of latex particles to other components of the pack.
  • Action
    Recall letters dated 8/4/08 were sent to the direct accounts on the same date, informing them that the labor and delivery packs were labeled Latex Free, but contained a Latex Nuk pacifier. The letters were customized for each account, listing the specific affected reorder numbers and lot numbers shipped to each account. The accounts were requested to immediately check their stocks for the affected lot numbers and quarantine the affected product found. The accounts were given three options: A) Attach the enclosed stickers to the packs so that the user is aware of the latex Nuk pacifier, B) Call Medline to receive replacement non-latex pacifiers, but also place the stickers on the packs, C) Return the packs to Medline for replacements. The accounts were requested to complete the enclosed response form, indicating which option the account selected and whether they needed any additional stickers, and fax the form back to Medline at 847-643-4482 by 8/18/08. Any questions were directed to Kathy Dunne at 1-866-359-1704.

Device

Medline Latex Free Vaginal Delivery CDSLF
  • Model / Serial
    VAGINAL DELIVERY CDS-LF reorder #CDS830006A, lots 05CD1909, 05ED0962, 05FD1796; reorder #CDS830014I, lots 06KD2998, 07AD2164, 07CD0437, 07ED0711, 07FD2205, 07GD3892, 07ID1876, 07ID2031;  reorder #CDS830014K, lots 07LD3284, 08DD0454, 08DD2313, 08FD1231, 08FD3833;  reorder #CDS830161B, lots 06JG0627, 06KG0324, 06KG0769, 06LG0181, 07BG0190, 07EG1256, 07FG0454, 07FG0684, 07FG0686, 07IG1497, 07LG191, 08AG2182, 08DG0043, 08FG1527, 06ED2094, 06FD0326, 06HD0006;
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
  • Product Description
    Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA