Z-0088-2019 Class II Terminated
FDA device recall Z-0088-2019 was initiated by MEDLINE INDUSTRIES INC on Aug 30, 2018 and is designated Class II. Reason for recall: Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. The recall status is terminated (terminated Feb 9, 2023). Affected quantity: 113,302 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Aug 30, 2018
- Termination Date
- Feb 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113,302 units
Product Description
Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.
Reason for Recall
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Distribution Pattern
United States, Taiwan, Chile
Code Information
Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0088-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026