Recall Z-0088-2019— MEDLINE INDUSTRIES INC
Class II · Terminated
Class II FDA medical device recall by MEDLINE INDUSTRIES INC, initiated 2018-08-30, terminated 2023-02-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold..
- Recalling firm
- MEDLINE INDUSTRIES INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-30
- Terminated
- 2023-02-09
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.