LUNA Chest, Model No. LU4006
FDA device recall Z-0469-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Novadaq Technologies, Inc.
- Reason for recall
- Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 828 units
- Distribution
- 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.
- Date initiated
- 2014-11-04
- Date posted
- 2014-12-01
- Date terminated
- 2015-11-06
- Location
- Canada, British Columbia
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPY FLUORESCENT IMAGING SYSTEM (K071619) | Novadaq Technologies, Inc. | 2007-11-09 |