FDAFDA · Food and drugs·Recall number Z-1595-2016
TCM CombiM Modules 903-111
Published May 11, 2016 · Recall initiated: November 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.
- Lot
- Part Number: 903-111 Lot Number: Below R0174
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.