Medical device recalls Moderate risk

3M Company - Health Care Business product recalled over labeling errors

Recall date
December 1, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
3M Company - Health Care Business recalls 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot nu…
Recall number
Z-0601-2016
FDA classification
Class II
Brand / firm
3M Company - Health Care Business
Sold / distributed
US nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

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