Events

Recall of Device Recall Dynarex CPR Shield With One Way Valve

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

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
    68681
  • Event Risk Class
    Class 2
  • Event Number
    Z-2117-2014
  • Event Initiated Date
    2014-07-02
  • Event Date Posted
    2014-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128445
  • 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
    Valve, non-rebreathing - Product Code CBP
  • Reason
    "this side up" is on the wrong side of the product. this error poses a potential health hazard if the wrong labeling is followed by caregivers.
  • Action
    Voluntary Device Recall letters (dated 7/01/14) and recall verification forms were sent to customers via US Postal First Class Mail on 7/02/14. The letters instructed customers to check their inventory for the specific lots, discontinue distributing them, and quarantine them immediately. Customers were to promptly contact Dynarex Credit & Return Representative Avi Celnick at 1-845-365-8200 ext. 6644 to arrange for product return and obtain an RGA #. For questions, please call Dynarex's toll free number 1-888-396-2739.

Device

Device Recall Dynarex CPR Shield With One Way Valve
  • Model / Serial
    Lot Numbers 28619 & 28621
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, and Mexico.
  • Product Description
    CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. || Used as a physical barrier for mouth to mouth resuscitation.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Manufacturer Address
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • Manufacturer Parent Company (2017)
    Dynarex Corporation
  • Source
    USFDA