Events

Recall of Device Recall Compat Nasogastric Feeding Tube

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

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
    65781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1922-2013
  • Event Initiated Date
    2013-07-24
  • Event Date Posted
    2013-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120128
  • 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
    Tube, feeding - Product Code FPD
  • Reason
    Nestle healthcare nutrition, inc. is initiating a recall on some of compat ng tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
  • Action
    Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.

Device

Device Recall Compat Nasogastric Feeding Tube
  • Model / Serial
    REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G  02412K 08211Z 08712W 14212U 14611P 21512Y 35411H  REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N  04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U  REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
  • Product Description
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). || Product Usage: || The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
  • Manufacturer
    Nestle HealthCare Nutrition

Manufacturer

Nestle HealthCare Nutrition
  • Manufacturer Address
    Nestle HealthCare Nutrition, 12500 Whitewater Dr, Minnetonka MN 55343-9420
  • Manufacturer Parent Company (2017)
    Nestlé S.A.
  • Source
    USFDA