Z-0088-2019Class II

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4...

Name: Z-0088-2019 Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4...
Creator: Medline Industries Inc
Published: 2018-08-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2018-08-30 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES INC began a recall of 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... on 2018-08-30. FDA classified it as Class II and gives the reason as "Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0088-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-10-06
Terminated: 2023-02-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: NEC Bandage, Liquid, Skin Protectant
Reason for recall: Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Root cause tag: manufacturing process
FDA 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 in commerce: 113,302 units
Distribution: United States, Taiwan, Chile
Product codes and lots: Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0088-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0088-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-06

Product code NEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)