ReNew (a.k.a. Trio) Dermatology: for use in dermatology recall: Labeling Error
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in…
Why was ReNew (a.k.a. Trio) Dermatology: for use in dermatology recalled?
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
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?
Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
- Product
- ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in…
- Recalling firm
- New Star Lasers, Inc.
- Quantity
- 5 systems
- Distribution
- US distribution only.
- Recall date
- October 12, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)