Events

Recall of Device Recall Stryker CBCII Collection only pkg/6 with 1/8 in Trocar

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
    54149
  • Event Risk Class
    Class 2
  • Event Number
    Z-0742-2010
  • Event Initiated Date
    2009-11-12
  • Event Date Posted
    2010-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87671
  • 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.

Device

Device Recall Stryker CBCII Collection only pkg/6 with 1/8 in Trocar
  • Model / Serial
    serial numbers 08016012 through 09115012.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S21. || Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
  • 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., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA