Events

Recall of Device Recall PERFEKTUM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Popper & Sons 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
    46322
  • Event Risk Class
    Class 3
  • Event Number
    Z-0881-2008
  • Event Initiated Date
    2008-01-02
  • Event Date Posted
    2008-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67180
  • 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
    Syringes (30 cc Lock tip) - Product Code FMI
  • Reason
    Mis-labeling: the product name on the label was erroneously declared as perfectum toomey evacuating syringes instead of popper interchangeable hypodermic syringes for one lot of the product. note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.
  • Action
    The recalling firm, Popper & Sons, began contacting its customers by telephone on/about 1/02/08, informing them of the issue. This was followed up with formal recall letters, Urgent Recall, and response forms starting on 1/09/08 via Certified Mail, Return Receipt Requested to the US accounts, and Registered Mail to the two Canadian accounts. The firm has directed the customers to discontinue using or distributing the lot and return any remaining quantity of this lot of syringes. If the lot has been further distributed, the distributors were instructed to immediately contact their accounts, advise them of the recall situation and have them return their outstanding recall stock as indicated above.

Device

Device Recall PERFEKTUM
  • Model / Serial
    Lot Number: B/503726-907-2
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA including the states of NY, NJ, PA, MI, IL, OH, FL, MO, TX, and CA, and country of Canada
  • Product Description
    PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040.
  • Manufacturer
    Popper & Sons Inc

Manufacturer

Popper & Sons Inc
  • Manufacturer Address
    Popper & Sons Inc, 300 Denton Avenue, New Hyde Park NY 11040-3437
  • Manufacturer Parent Company (2017)
    Joseph G Popper & Sons Inc
  • Source
    USFDA