Device product
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Z-1495-2026
Product summary
- Firm
- KOB GmbH
- Event
- Event 98328
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35,328
- Official record key
device-enforcement:Z-1495-2026
Official wording
Reason: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Code information: Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
Distribution pattern: U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
Derived failure modes
-
Labeling or packaging
labeling error. Incomplete