Events

Recall of Device Recall CBC II Wound Drain

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-1564-2015
  • 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=135088
  • 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 Drain
  • Model / Serial
    Part Number: 0215-018-000 and lot numbers: 10076012 10284012 11108012 11280012 12110012 12334012 13158012 14020012 10095012 10292012 11117012 11298012 12131012 12338012 13182012 14050012 10103012 10295012 11125012 11305012 12143012 12339012 13191012 14056012 10112012 10307012 11136012 11308012 12153012 12348012 13220012 14059012 10125012 10319012 11143012 11339012 12158012 12352012 13227012 14076012 10133012 10335012 11145012 11343012 12160012 13011012 13238012 14083012 10137012 10342012 11146012 11356012 12164012 13035012 13239012 14147012 10160012 10356012 11157012 12012012 12181012 13050012 13261012 14165012 10175012 11010012 11161012 12019012 12188012 13059012 13262012 14169012 10188012 11014012 11187012 12030012 12242012 13078012 13274012 14174012 10205012 11026012 11204012 12051012 12255012 13091012 13281012 14189012 10222012 11032012 11221012 12053012 12262012 13099012 13298012 14190012 10228012 11043012 11230012 12055012 12277012 13106012 13323012 14231012 10237012 11053012 11249012 12061012 12292012 13113012 13324012 14233012 10252012 11069012 11251012 12065012 12303012 13138012 13340022 14245012 10266012 11088012 11265012 12081012 12313012 13144012 13351012 14280012 10273012 11103012 11269012 12091012 12317012 13155012 14017012 14344012
  • 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
    1/8 in. Trocar with Single 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