FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
- Recall number
- Z-0601-2016
- Recalling firm
- 3M Company - Health Care Business
- Product
- 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
- Status
- Terminated
- Initiated
- 2015-12-01
- Posted
- not on file
- Terminated
- 2016-05-24
- 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.
- 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
- 167 cases (30 rolls/case)
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMP
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28