Events

Recall of Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by K C Pharmaceuticals 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
    54656
  • Event Risk Class
    Class 2
  • Event Number
    Z-1225-2010
  • Event Initiated Date
    2010-02-03
  • Event Date Posted
    2010-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88914
  • 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
    Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
  • Reason
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Action
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.

Device

Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Model / Serial
    Lot #9D524.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297. || This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
  • Manufacturer
    K C Pharmaceuticals Inc

Manufacturer

K C Pharmaceuticals Inc
  • Manufacturer Address
    K C Pharmaceuticals Inc, 3201 Producer Way, Pomona CA 91768-3916
  • Manufacturer Parent Company (2017)
    Kc Pharmaceuticals Inc.
  • Source
    USFDA