Events

Recall of Device Recall Medela Enteral Syringe, Acacia Piston Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medela Inc. EF Division.

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
    70544
  • Event Risk Class
    Class 2
  • Event Number
    Z-1262-2015
  • Event Initiated Date
    2015-02-13
  • Event Date Posted
    2015-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134006
  • 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
    Syringe, piston - Product Code FMF
  • Reason
    The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
  • Action
    Medela sent a Device Recall letter dated February 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Requested Action of Distributors: 1. Stop sale and distribution of product with affected lot numbers. 2. Conduct a physical count and record the data on the Product Inventory Form included with the letter. 3. Return the Product Inventory Form via fax to 800-995-7867 or e-mail it to syringe@medela.com. The firm should contain a contact name and signature. 4. If have the affected product in stock, Medela Customer Service will issue a RMA and schedule a pick-up of the affected product. Contact will be made to ensure product is ready. For further questions please call (888) 399-2455.

Device

Device Recall Medela Enteral Syringe, Acacia Piston Syringe
  • Model / Serial
    NTL-30 G0556, G0561, G0572, G0585, G0593, G0601, G0610, G0614, G0622, G0634, G0644, G0649, G0653, G0662, G0667, G0672, G0683, G0684, G0685, G0698, G0705, G0708, G0711, G0712, G0714, G0716, G0723, G0719, G0726, G0734, G0744, G0750, G0752, G0760  NTL-60 G0554, G0566, G0578, G0594, G0598, G0612, G0615, G0623, G0626, G0636, G0639, G0650, G0657, G0658, G0659, G0665, G0668, G0670, G0671, G0673, G0679, G0680, G0686, G0687, G0691, G0699, G0703, G0706, G0709, G0715, G0722, G0725, G0729, G0735, G0739, G0741, G0745, G0751, G0756, G0761  TL-INT-60 G0563, G0565, G0577, G0663, G0701, G0710, G0713, G0733, G0737, G0753  INT-60 G0555, G0567, G0575, G0587, G0591, G0603, G0620, G0638, G0640, G0648, G0664, G0690, G0718, G0746  NGF-60 G0550, G0560, G0568, G0576, G0592, G0609, G0628, G0646, G0655, G0675, G0688, G0697, G0707, G0724, G0730, G0728, G0743, G0754
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) || - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) || - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) || - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) || - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) || The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
  • Manufacturer
    Medela Inc. EF Division

Manufacturer

Medela Inc. EF Division
  • Manufacturer Address
    Medela Inc. EF Division, 785 Challenger St, Brea CA 92821-2948
  • Source
    USFDA