This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Natus Comments On FDA Recall

Natus Medical Incorporated (Nasdaq:BABY) today released a statement regarding the issuance by the Food & Drug Administration (the “FDA”) of a recall notice for the Company’s Olympic Cool-Cap.

The recall addresses a situation where the Cool-Cap screen freezes and interrupts patient cooling. Natus had previously communicated the problem to customers in May 2012 by issuing a Class II Recall notice, which is the FDA’s mid-level health hazard classification. Customers are able to recover from the screen freeze failure by simply rebooting the Cool-Cap system. Cooling treatment can continue in a safe manner with the Cool-Cap system as originally intended.

The Company has provided recall information to the FDA as required in a timely manner since this problem originated. Today’s announcement indicates that the FDA has re-classified this action as a Class I Recall which is the highest relative degree of health hazard classification for a product recall. As a result of this reclassification, Natus will be sending follow up Safety Notice letters to all customers reminding them how to recognize this screen freeze condition and how to recover from it. Separately, an unreliable power supply module is being replaced on an ongoing basis in effected units.

The costs of the measures described above are not expected to be material, including costs yet to be incurred, and were previously accrued as an expense in the Company’s financial results for the nine months ended September 30, 2012.

The recall does not prevent the Company from continuing to market and sell the Cool-Cap, nor does it prevent clinicians from using the device. Revenue from the Cool-Cap represents less than one percent of the Company’s consolidated revenue.

The Company received premarket approval (“PMA”) from the FDA to market the Olympic Cool-Cap in December 2006. The Cool-Cap system, which is the only FDA-approved device for the treatment of hypoxic ischemic encephalopathy (“HIE”) in term newborns, provides selective head cooling to prevent or reduce the severity of neurologic injury associated with HIE.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,265.99 +109.14 0.64%
S&P 500 2,011.36 +9.79 0.49%
NASDAQ 4,593.4250 +31.2360 0.68%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs