LUNA Chest recall: Labeling Error
LUNA Chest, Model No. LU4006
Why was LUNA Chest recalled?
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
- Product
- LUNA Chest, Model No. LU4006
- Recalling firm
- Novadaq Technologies, Inc.
- Quantity
- 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.
- Recall date
- December 3, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)