Events

Recall of Device Recall PSD/4 Syringe Drive module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton Co.

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
    33435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0087-06
  • Event Initiated Date
    2005-08-24
  • Event Date Posted
    2005-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41880
  • 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
    Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use - Product Code JJC
  • Reason
    The product valve has a high probability of deforming and may result in leakage during use.
  • Action
    Recall initiated on 08/24/2005. The firm issued notification to its consignees via overnight letter, and via e-mail for its distributor (Hamilton Bonaduz).

Device

Device Recall PSD/4 Syringe Drive module
  • Model / Serial
    catalog number 7427-01 (Y-valve), catalog number 7990-01 (T-valve), catalog number 51863-01-IL (PSD/4 with valve and syringe), no 510k number.  For 7427-01 (Lot number, date of manufacture): 277702, 4/29/2003; 282550A, 8/11/2003; 282550, 8/13/2003; 286630, 10/1/2003; 287449, 10/20/2003; 287137, 10/20/2003; 287949, 12/18/2003; 301809, 6/30/2004; 305599, 8/19/2005; 309328, 11/5/2004; 313276, 12/17/2004; 314662, 3/7/2005; 317940, 4/6/2005; 319506, 4/11/2005; 321121, 5/6/2005; 324204, 6/23/2005; 325483, 7/20/2005.  For 7990-01: 277703, 4/30/2003; 283119, 9/30/2003 291279, 1/7/2004; 303942, 7/19/2004; 303687, 7/19/2004; 318833, 3/24/2005; 319684, 5/5/2005.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.
  • Product Description
    Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
  • Manufacturer
    Hamilton Co

Manufacturer

Hamilton Co
  • Manufacturer Address
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA