Events

Recall of Device Recall NAMIC Convenience Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Navilyst Medical, 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
    60729
  • Event Risk Class
    Class 2
  • Event Number
    Z-0821-2012
  • Event Initiated Date
    2011-12-19
  • Event Date Posted
    2012-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106322
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Reason
    Navilyst medical has received reports of damaged manifolds contained in certain namic convenience kits which may result in air injection during certain procedures.
  • Action
    Navilyst Medical sent an Urgent Medical Device Recall- Immediate Action Required letter dated December 19, 2011 and a Reply Verification Tracking Form to all affected consignees via Federal Express or email. The letter identified the product, description of problem, and actions to be taken Customers were instructed to 1) IMMEDIATELY DISCONTINUE USE; 2) remove the recalled product from your inventory (whether in Labs, Central Supply, Shipping and Receiving or ANY other location); 3) segregate this product in a secure location for return to Navilyst Medical, Inc; 4) immediately forward a copy of this recall notification to all sites to which you have distributed affected product; 5) complete and return the Reply Verification Tracking Form; and 6) package and return the recalled product per the instruction provided.

Device

Device Recall NAMIC Convenience Kit
  • Model / Serial
    Sterile/Non-Sterile UPN Cat Num Lot Sterile Kit H749600183811 60018381 4163389;  Sterile Kit H749600308161 60030816 4155011;  Sterile Kit H749600339121 60033912 4167674;  Sterile Kit H7496005216131 60052161 4148470;  Sterile Kit H7496005216131 60052161 4152176;  Sterile Kit H7496005216131 60052161 4166769;  Sterile Kit H7496005216131 60052161 4168829;  Sterile Kit H7496005216131 60052161 4170180;  Sterile Kit H749601621861 60162186 4173288;  Sterile Kit H749601921911 60192191 4155123;  Sterile Kit H749602103071 60210307 4155130;  Sterile Kit H749602103071 60210307 4160686;  Sterile Kit H749606912341 60691234 4175188;  Sterile Kit H965600102351 60010235 4155678;  Sterile Kit H965600104921 60010492 4153182;  Sterile Kit H965600204051 60020405 4155226;  Sterile Kit H965600204051 60020405 4172242;  Sterile Kit H965600206451 60020645 4155233;  Sterile Kit H965600300681 60030068 4166803;  Sterile Kit H965600800511 60080051 4155288;  Sterile Kit H965600800511 60080051 4169451;  Sterile Kit H965601001351 60100135 4154699;  Sterile Kit H965601001351 60100135 4165389;  Sterile Kit H965601001351 60100135 4168350;  Sterile Kit H965601001351 60100135 4169879;  Sterile Kit H965601001351 60100135 4172683;  Sterile Kit H965601001351 60100135 4176389;  Sterile Kit H965602100141 60210014 4160703;  Sterile Kit H965602201531 60220153 4155363;  Sterile Kit H965PK050455S1 PK050455S 4177156;  Non-Sterile Kit H749650300641 65030064 4148480;  Non-Sterile Kit H749650300641 65030064 4168790;  Non-Sterile Kit H749650302721 64030272 4167954;  Non-Sterile Kit H749651106561 65110656 4169591;  Non-Sterile Kit H749651106561 65110656 4172687;  Non-Sterile Kit H749656900411 65690041 4166791;  Non-Sterile Kit H965650200691 65020069 4169026;  Non-Sterile Kit H965651949131 65194913 4157481;  Non-Sterile Kit H965651949131 65194913 4174714;  Non-Sterile Kit H9656522016141 652201614 4167686; Non-Sterile Kit H9656522016141 652201614 4170421;
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, South Carolina, Wisconsin, Virginia and the country of Japan.
  • Product Description
    NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. || Product usage: For use in fluid management and/or invasive pressure monitoring systems
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
    Navilyst Medical, Inc
  • Source
    USFDA