FDAClass IIMarch 28, 2018

Neonatal IV Access SET recall

NEONATAL IV ACCESS SET

Why was Neonatal IV Access SET 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?

IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

Product
NEONATAL IV ACCESS SET
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