Z-1950-2021 Class II Ongoing
FDA device recall Z-1950-2021 was initiated by EHOB, Inc. on April 19, 2021 and is designated Class II. Reason for recall: Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates The recall status is ongoing. Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- April 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
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 Pattern
US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
Code Information
Lot Number: 105013A