Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0088-2019 · Posted None

Recalling FirmMEDLINE INDUSTRIES INC
Recall StatusTerminated
Product CodeNEC
Date Initiated2018-08-30
Date Terminated2023-02-09
Product Quantity113,302 units

Reason for Recall

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

Firm 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.

Root Cause

Environmental control

Distribution Pattern

United States, Taiwan, Chile

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑