Z-0470-2015 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- November 4, 2014
- Termination Date
- November 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 324 units
Product Description
Non-sterile drape
Reason for Recall
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Distribution Pattern
Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
Code Information
Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282