FDA recall Z-0416-2018
Molnlycke Health Care, Inc · Class II · device
Product
7x10" Small Utility Positioner with Cover
Reason for recall
Products may not meet specifications due to possible presence of metal shavings.
Distribution
Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
Key facts
- Status
- Terminated
- Initiation date
- 2017-07-26
- Report date
- 2018-02-07
- Termination date
- 2021-04-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Norcross, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2018