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Terminated

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

FDA Recall Z-0601-2016 · Posted None

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeFMP
Date Initiated2015-12-01
Date Terminated2016-05-24
Product Quantity167 cases (30 rolls/case)

Reason for Recall

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.

Firm Action

Consignees were sent via certified mail on 12/1/2015 a 3M letter dated November 25, 2015 and an emal on 12/5/2015 for the updated 3M "Urgent Medical Device" letter dated November 25, 2015. The letter was addressed to 3M Health Care Distributor. The letter described the problem, device involved in the recall and the action required. Advised consignees to quarantine the product, notify their customers and to complete and return the "Product Recall Form". Distributors were also provided with a "Customer" letter for distribution. For questions contact 3M Customer Helpline 1-800-228-3957.

Root Cause

Process control

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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