Events

Recall of Device Recall stapler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EXP Pharmaceutical Services Corp.

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
    71608
  • Event Risk Class
    Class 2
  • Event Number
    Z-2224-2015
  • Event Initiated Date
    2015-02-11
  • Event Date Posted
    2015-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138371
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    Exp did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
  • Action
    EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

Device

Device Recall stapler
  • Model / Serial
    OEM Catalog number 173054.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 173054; || EXP (repackager), Tyco (OEM) || Laparoscope, General & Plastic Surgery
  • Manufacturer
    EXP Pharmaceutical Services Corp

Manufacturer

EXP Pharmaceutical Services Corp
  • Manufacturer Address
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • Manufacturer Parent Company (2017)
    Abry Partners Inc.
  • Source
    USFDA