Medline Recalls Unna Boot Compression Wraps Due to Mold Contamination
Medline Industries is recalling Unna Boot Compression Wraps because sporadic reports identified common mold on certain lots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a biological contaminant (mold) on a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries Inc. is recalling Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers NONUNNA3 and NONUNNA4. The recall involves 113,302 units distributed in the United States, Taiwan, and Chile. The product is packaged in a foil pouch inside a box carton, with 12 cartons per case.
The recall was initiated after the firm received sporadic reports of discoloration on certain lots of the product. This discoloration has been identified as common mold. The affected lot numbers for Item Number NONUNNA3 are 70112, 70485, 70602, 80637, 80663, and 80719. The affected lot numbers for Item Number NONUNNA4 are 70182, 70593, 80638, 80644, 80660, 80709, and 80712.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should check their inventory for the specific item numbers and lot numbers listed above and stop using the affected products.
The recalled product
- 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.
- Manufacturer
- MEDLINE INDUSTRIES INC
- Hazard
- Affected units
- 113,302
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot numbers: a) NONUNNA3: 70112
- 70485
- 70602
- 80637
- 80663
- and 80719. b) NONUNNA4: 70182
- 70593
- 80638
- 80644
- 80660
- 80709 and 80712.
Distribution
Distribution scope not specified by the agency.
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