Z-0601-2016 Class II Terminated
FDA device recall Z-0601-2016 was initiated by 3M Company - Health Care Business on Dec 1, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 24, 2016). Affected quantity: 167 cases (30 rolls/case).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 13, 2016
- Initiation Date
- Dec 1, 2015
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 cases (30 rolls/case)
Product 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 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.
Distribution Pattern
US nationwide distribution.
Code Information
Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0601-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026