Events

Recall of Device Recall Sierra PerFilled

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AM2 PAT 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
    46182
  • Event Risk Class
    Class 1
  • Event Number
    Z-0832-2008
  • Event Initiated Date
    2007-12-11
  • Event Date Posted
    2008-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67380
  • 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
    Saline IV Flush Pre Filled Syringe - Product Code FOZ
  • Reason
    Lack of assurance of sterility by manufacturer.
  • Action
    AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.

Device

Device Recall Sierra PerFilled
  • Model / Serial
    ALL LOTS
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
  • Manufacturer
    AM2 PAT INC

Manufacturer

AM2 PAT INC
  • Manufacturer Address
    AM2 PAT INC, 455 W Depot Street, Angier NC 27501
  • Manufacturer Parent Company (2017)
    Sierra Pre-Filled/AM2PAT
  • Source
    USFDA