Events

Recall of Device Recall CBC II Wound Drains

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    70841
  • Event Risk Class
    Class 2
  • Event Number
    Z-1563-2015
  • Event Initiated Date
    2015-03-26
  • Event Date Posted
    2015-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135087
  • 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
    Stryker instruments is voluntarily recalling the cbcii wound drains and ambulating bulb for a potential sterility breach in the packaging.
  • Action
    An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.

Device

Device Recall CBC II Wound Drains
  • Model / Serial
    Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
  • Product Description
    3/16 in. Double Trocar with Wound Drain || Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA