Events

Recall of Device Recall MEDLINE ADULT MANUAL RESUSCITATOR

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

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
    80201
  • Event Risk Class
    Class 2
  • Event Number
    Z-2151-2018
  • Event Initiated Date
    2018-05-24
  • 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=164850
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Reason
    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
  • Action
    On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible. 4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly. Customers with questions can call 1-800-433-2797 or email info@sun-med.com

Device

Device Recall MEDLINE ADULT MANUAL RESUSCITATOR
  • Model / Serial
    Lot Numbers: 313326, 313436 & 313049
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IL & OH distributors
  • Product Description
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
  • Manufacturer
    Sun Med, LLC

Manufacturer

Sun Med, LLC
  • Manufacturer Address
    Sun Med, LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Source
    USFDA