FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES INC: 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.
- Recall number
- Z-0088-2019
- Recalling firm
- MEDLINE INDUSTRIES INC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-08-30
- Posted
- not on file
- Terminated
- 2023-02-09
- Reason
- Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
- Root cause
- Environmental control
- Action
- On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm.
- Quantity
- 113,302 units
- Distribution
- United States, Taiwan, Chile
- Lot, serial or model codes
- Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEC
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28