Events

Recall of Device Recall safePICO Samplers Syringes equipped w/safe tip caps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    36009
  • Event Risk Class
    Class 2
  • Event Number
    Z-1443-06
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47485
  • 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
    blood samplers - Product Code JKA
  • Reason
    Leaking tip caps-tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
  • Action
    The firm sent a recall letter to their customers on 7/18/2006. The letter identifies the problem, as well as the Part Numbers and Lot Numbers for the defective safePICO syringes subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected part numbers and lot numbers; 2) Identify and discard any of the affected product found on-hand; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.

Device

Device Recall safePICO Samplers Syringes equipped w/safe tip caps
  • Model / Serial
    The recalled product is identified with the following Part Numbers/Order No.; Lot Numbers; and Expiration Dates:  Part #956-610, Lot #RD-28, and Expiration Date: 2008-01; Part #956-612, Lot #RJ-05, and Expiration Date: 2008-02; Part #956-614, Lot #RL-30, Expiration Date: 2008-03, Part #956-616, Lot #RQ-02, Expiration Date: 2008-04; and Part #956-623, Lot Code: RL22, and Expiration Date:2008-03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
  • Product Description
    SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. || The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA