Zinc paste bandage labeling omitted castor oil and calamine ingredients
KOB GmbH is recalling Medline Unna-Z Stretch Zinc Paste Bandage because of a labeling error: the ingredients list did not include castor oil or calamine.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the source describes an incomplete ingredients list with no hazard, reaction or injury stated.
Plain-English summary
KOB GmbH is recalling the Medline Unna-Z Stretch Zinc Paste Bandage, REF NONUNNAS40, KOB article #40307010. About 35,328 units were distributed, with US distribution in Illinois. The FDA has classified this recall as Class II.
The recall was initiated due to a labelling error: incomplete ingredients were listed. The labelling did not include castor oil or calamine.
Affected product carries customer code 10888277675438 across lots 2520206 and 2520739.
Facilities can identify affected product by the REF, article number and lot numbers above, and may contact KOB GmbH for further information.
The recalled product
- Product
- MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
- Manufacturer
- KOB GmbH
- Category
- Medical Device — Wound care
- Affected units
- 35,328
Distribution
Distributed in 1 state:
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