FDAClass IIMarch 2, 2022

Bard Surestep Intermittent Catheter Tray recall

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Why was Bard Surestep Intermittent Catheter Tray recalled?

There is a potential to leak from the catheter where it connects to the drain bag

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?

Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Recalling firm
C.R. Bard Inc
Quantity
1620 units
Distribution
US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Recall date
March 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls