Recall of Device Recall Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Apparatus, autotransfusion - Product Code cac
  • Reason
    The product may not be sterile due to package not being intact.
  • Action
    Stryker issued a "Medical Device Recall Notification" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm. For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808.


  • Model / Serial
    serial numbers 07311012 through 09183022.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-614. || Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
  • Manufacturer


  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
  • Source