Events

Recall of Device Recall Medline

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MMS Sales Corp.

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
    31451
  • Event Risk Class
    Class 2
  • Event Number
    Z-0768-05
  • Event Initiated Date
    2005-02-21
  • Event Date Posted
    2005-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37994
  • 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
    Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
  • Reason
    Partial occlusion in the t-piece resulting in airway obstruction.
  • Action
    The firm initiated the recall on February 21, 2004 by letter to all consignees.

Device

Device Recall Medline
  • Model / Serial
    Part Number DYNJAAF6225, 20 per case, Lot Number: 574481104;  Part Number DYNJAAF6261, 20 per case, Lot Numbers: 570601004, 577491104, 578371104;  Part Number DYNJAPF4000, 20 per case, Lot Numbers: 570701004, 589820105, 590030105, 593300105, 597460105
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • Product Description
    Circuit-Unilimb, Adult, 1M (40''), Disposable, Clean Non-sterile, Adult Anesthesia Circuit, Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261. Manufactured for Medline Industries, Inc., Mundelein, IL 60060, Made in Mexico.
  • Manufacturer
    MMS Sales Corp

Manufacturer

MMS Sales Corp
  • Manufacturer Address
    MMS Sales Corp, 218 Highline Rd, Pharr TX 78577-9726
  • Source
    USFDA