FDAClass IIMarch 28, 2018

Catheter Securement System recall

CATHETER SECUREMENT SYSTEM

Why was Catheter Securement System recalled?

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

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?

CSS490 Lot codes: 2016022290 2017071790

Product
CATHETER SECUREMENT SYSTEM
Recalling firm
Centurion Medical Products Corporation
Quantity
N/A
Distribution
Nationally
Recall date
March 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls