Z-0298-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2018
- Initiation Date
- June 5, 2017
- Termination Date
- March 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Reason for Recall
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Distribution Pattern
Nationwide in US; Internationally Argentina, Netherlands & Canada
Code Information
Lot Number: 529890