UniPerc(R) Adjustable Flange Tracheostomy Tube kit recall
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical…
Why was UniPerc(R) Adjustable Flange Tracheostomy Tube kit recalled?
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
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 3308971
- Product
- UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical…
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 89 units
- Distribution
- INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
- Recall date
- October 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)