FDA Enforcement
Class II
Terminated
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Recall: Z-0601-2016
·
Reported January 13, 2016
Enforcement
- Recall Number
- Z-0601-2016
- Event ID
- 72780
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- 3M Company - Health Care Business
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 13, 2016
- Initiation Date
- December 1, 2015
- Classification Date
- January 6, 2016
- Termination Date
- May 24, 2016
- Address
- 3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144-0001, United States
Description
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
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.
Code Info
Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
Distribution
US nationwide distribution.
Quantity
167 cases (30 rolls/case)