FDAClass IIOctober 10, 2012

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with recall

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The…

Why was 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with recalled?

The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

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?

Catalog # 165808, Lot # NGWA1111

Product
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The…
Recalling firm
C.R. Bard, Inc., Urological Division
Quantity
4,032 units
Distribution
Nationwide distribution: USA and Puerto Rico
Recall date
October 10, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls