Device product
Non-sterile drape
Z-0470-2015
Product summary
- Event
- Event 69839
- Status
- Terminated
- Classification
- Class III
- Quantity
- 324 units
- Official record key
device-enforcement:Z-0470-2015
Official wording
Reason: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Code information: Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282
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.
Derived failure modes
-
Labeling or packaging
mislabeled