Gyrus ACMI Diego Elite Tubeset recall: Sterility Concern
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT…
Why was Gyrus ACMI Diego Elite Tubeset recalled?
Potential lack of sterility assurance.
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?
Lot number: JC929332
- Product
- Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT…
- Recalling firm
- Gyrus Acmi, Incorporated
- Quantity
- 12,020 boxes
- Distribution
- Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
- Recall date
- June 17, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)