FDA recall Z-1950-2021

Product

Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

Reason for recall

Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

Distribution

US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.

Key facts

Status

Ongoing

Initiation date

2021-04-19

Report date

2021-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2021