Z-0601-2016Class II

3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog...

Name: Z-0601-2016 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog...
Creator: 3M Company - Health Care Business
Published: 2015-12-01
License: https://open.fda.gov/license/

3M Company / initiated 2015-12-01 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM on 2015-12-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0601-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2016-01-06
Terminated: 2016-05-24
Recalling firm: 3M Company
Product: 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Product code: FMP Protector, Skin Pressure
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 167 cases (30 rolls/case)
Distribution: US nationwide distribution.
Product codes and lots: Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0601-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0601-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code FMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)