Smiths Medical Portex Bivona Pediatric Tracheostomy recall
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Why was Smiths Medical Portex Bivona Pediatric Tracheostomy recalled?
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 #4125816, exp. 3/17/2026, UDI-DI 15021312005769.
- Product
- Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- N/A
- Distribution
- Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)