The Recall Desk
HighFDA (Devices)·Z-0601-2016·Announced 2016-01-13

3M Coban Self-Adherent Wrap Recalled for Latex Mislabeling

3M is recalling Coban Self-Adherent Wrap mislabeled as latex-free because it actually contains latex, posing a risk to users with latex sensitivity.

What this means for you

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 involves allergen mislabeling (latex) on a medical device, which fits the rubric criterion for 'Allergen mislabeling on common allergens' and 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

3M Company - Health Care Business is recalling 3M Coban Self-Adherent Wrap that was mislabeled as latex-free. The shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. However, the actual product is Catalog number 1581, lot 2020-10AN, which contains latex.

The recall is being conducted because the product contains latex despite being labeled as latex-free. This mislabeling could pose a health risk to users with sensitivity or allergic reactions to latex, with symptoms ranging from mild to severe. The recall involves 167 cases (30 rolls per case) that were distributed nationwide in the US.

Consumers and healthcare facilities should check their inventory for the specific lot and catalog numbers listed above. If the product is found, it should be removed from use and returned to the supplier or 3M for credit or replacement, following standard recall procedures.

The recalled product

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

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 (3)

  • Catalog# 1581
  • lot # 2020-10AN Catalog# 2081
  • lot # 2018-AM (shipper carton)

Distribution

Distributed nationwide across the United States.