Pediatric Adjustable Flange Tracheostomy Tube Cuffless recall
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Why was Pediatric Adjustable Flange Tracheostomy Tube Cuffless recalled?
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
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?
Model Number: 60HA30, Lot: 3794165, SKU 60HA30
- Product
- Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 20 devices
- Distribution
- U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)