Events

Recall of Device Recall HEPARIN LOCK FLUSH SOLUTION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by App Pharmaceuticals 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
    57878
  • Event Risk Class
    Class 2
  • Event Number
    Z-1825-2012
  • Event Initiated Date
    2010-05-20
  • Event Date Posted
    2012-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109646
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Reason
    Cgmp deviations: incomplete documentation associated with test results.
  • Action
    APP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.

Device

Device Recall HEPARIN LOCK FLUSH SOLUTION
  • Model / Serial
    Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Product Description
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only || To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
  • Manufacturer
    App Pharmaceuticals Llc

Manufacturer

App Pharmaceuticals Llc
  • Manufacturer Address
    App Pharmaceuticals Llc, 1501 E Woodfield Rd, Suite 300 East, Schaumburg IL 60173-6052
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA