Z-3208-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- July 11, 2018
- Termination Date
- August 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27515 total
Product Description
P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
Reason for Recall
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Distribution Pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
Code Information
1814906864