Z-3031-2017 Class II Terminated
FDA device recall Z-3031-2017 was initiated by ICU Medical Inc on June 15, 2017 and is designated Class II. Reason for recall: Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therap… The recall status is terminated (terminated April 17, 2020). Affected quantity: 68,559 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2017
- Initiation Date
- June 15, 2017
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,559 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.