Events

Recall of Device Recall Reprocessed Ethicon Xcel Trocar Sleeve

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

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
    71805
  • Event Risk Class
    Class 2
  • Event Number
    Z-2468-2015
  • Event Initiated Date
    2015-07-10
  • Event Date Posted
    2015-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139129
  • 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
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • Reason
    Stryker sustainability solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (cb5lt) while the devices inside of the packaging were 75mm models (cb5st).
  • Action
    On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. The form must be completed even if no affected devices are found in inventory. Stryker Sustainability Solutions Complaint Hotline: 1-888-888-3433 x5555

Device

Device Recall Reprocessed Ethicon Xcel Trocar Sleeve
  • Model / Serial
    Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
  • Product Description
    Stryker || Sustainability Solutions || CB5LT || Ethicon Endo-Surgery, Inc. || Excel Trocar Sleeve || w/Stability Sleeve || 5mm x 100mm || Reprocessed by Stryker Sustainability Solutions || Product Usage: || The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA