Events

Recall of Device Recall Codman Cetras

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codman & Shurtleff, Inc..

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
    68837
  • Event Risk Class
    Class 2
  • Event Number
    Z-2189-2014
  • Event Initiated Date
    2014-07-03
  • Event Date Posted
    2014-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128831
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Reason
    To clarify the codman certas valve virtual off (setting 8) pressure specification outlined in the product's instructions for use (ifu).
  • Action
    Codman Neuro sent an Urgent Medical Device Safety Notification dated July 17, 2014, to clinicians who use the device. The notification clarifies the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). Consignees are also asked to complete the enclosed Acknowledgement Form and fax the completed form to 1-888-239-1305. For questions or concerns regarding this notification, consignees are instructed to contact their local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325. For questions regarding this recall call 508-828-2726.

Device

Device Recall Codman Cetras
  • Model / Serial
    Lot Numbers: CMBC2Y, CMDCN9, CMJC48, CMLC6D, CMNBFF, CMNCDY, CNCB6M, CNCCLB, CNCCZ4, CNDBRG, CNDCNB, CNHC8M, CNJC4P, CNKCL4, CNLCL1, CNMB8Y, CNMDMO, CNNDHY, CNPCLZ, CPBC99, CPBCRZ, CPCC27, CPDBYJ, CPDCKL
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
  • Product Description
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 || The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Manufacturer Address
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA