Events

Recall of Device Recall Synergetics 25 gauge Soft Tip Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synergetics 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
    65969
  • Event Risk Class
    Class 2
  • Event Number
    Z-0051-2014
  • Event Initiated Date
    2013-07-30
  • Event Date Posted
    2013-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121103
  • 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
    Cannula, ophthalmic - Product Code HMX
  • Reason
    One lot of 25 gauge soft-tip disposable cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
  • Action
    The firm sent recall notification letters to their consignees on 7/30/13.

Device

Device Recall Synergetics 25 gauge Soft Tip Cannula
  • Model / Serial
    Lot number: M222240
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
  • Product Description
    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. || Single-use 25 gauge cannula used in vitreoretinal surgery.
  • Manufacturer
    Synergetics Inc

Manufacturer

Synergetics Inc
  • Manufacturer Address
    Synergetics Inc, 3845 Corporate Centre Dr, O Fallon MO 63368-8678
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA