Device product
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Z-0601-2016
Product summary
- Event
- Event 72780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 cases (30 rolls/case)
- Official record key
device-enforcement:Z-0601-2016
Official wording
Reason: Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
Code information: Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Labeling or packaging
mislabeled