Events

Recall of Blue OR Towels

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Action 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
    77063
  • Event Risk Class
    Class 2
  • Event Number
    Z-2102-2017
  • Event Initiated Date
    2017-04-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154915
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Reason
    Lint present on sterile operating room towels.
  • Action
    Consignees were notified via Medical Device Notification of Recall notice on/about 4/19/2017.

Device

Blue OR Towels
  • Model / Serial
    Material Number: AVID260, Lot #231253, Exp. Date: 10/31/2021 (48 pk) and Material Number: MSPT504, Lot #229259, Exp. Date: 10/12/2021 (20 pk).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AR, IN and NV.
  • Product Description
    Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). || Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Manufacturer Address
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Manufacturer Parent Company (2017)
    Owens & Minor Inc
  • Source
    USFDA