FDAClass IIOctober 30, 2024

smiths medical portex recall

smiths medical portex, Y' PIECE 15MM, REF 100/276/000

Why was smiths medical portex recalled?

Uncertainty in the seal integrity of the sterile packaging.

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?

UDI/DI 35019315011003, Lot Numbers: 4131841, UDI/DI 35019315022405, Lot Numbers: 4122012, 4133227

Product
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Recalling firm
Smiths Medical ASD Inc.
Quantity
9,133 units
Distribution
Worldwide distribution.
Recall date
October 30, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls