LUNA Chest, Model No. LU4006
Recall
- Recall Number
- Z-0469-2015
- Event Number
- 69839
- Firm
- Novadaq Technologies, Inc. 13155 Delf Place Richmond Canada British Columbia
- FEI Number
- 3008177327
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- November 4, 2014
- Posted
- December 1, 2014
- Terminated
- November 6, 2015
Description
LUNA Chest, Model No. LU4006
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Novadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861.
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.
828 units