Z-0314-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 17, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 devices
Product Description
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Reason for Recall
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Distribution Pattern
U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom
Code Information
Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)