Device 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
Z-1950-2021
Product summary
- Firm
- EHOB, Inc.
- Event
- Event 87864
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-1950-2021
Official wording
Reason: Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
Code information: Lot Number: 105013A
Distribution pattern: US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
Derived failure modes
-
Unknown
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates