Events

Recall of Doyle AbsorbENT Nasal Pack w/airway & string

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Summit Medical, 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
    72276
  • Event Risk Class
    Class 2
  • Event Number
    Z-0435-2016
  • Event Initiated Date
    2015-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140459
  • 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
    Applicator, ent drug - Product Code LRD
  • Reason
    Summit medical is recalling doyle p/f nasal pack w/airway, string 8 cm x 3 cm x 1.5 cm, catalog # rh-7413-10, lot # 160889 & 161354 because the product does not have the split in the packing.
  • Action
    Consignees were sent a Summit Medical "Medical Device Recall" letter, dated September 2, 2015. The letter described the problem and the product involved in the recall. It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product. For questions, contact Nicole Dove at 651-789-3921 or ndove@summitmedicalusa.com.

Device

Doyle AbsorbENT Nasal Pack w/airway & string
  • Model / Serial
    160889, 161354
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to CA.
  • Product Description
    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. || Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
  • Manufacturer
    Summit Medical, Inc.

Manufacturer

Summit Medical, Inc.
  • Manufacturer Address
    Summit Medical, Inc., 815 Northwest Pkwy Ste 100, Eagan MN 55121-1658
  • Source
    USFDA