FDA recall Z-3205-2018

Product

400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD

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

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.

Key facts

Status

Terminated

Initiation date

2018-07-11

Report date

2018-09-26

Termination date

2020-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3205-2018