FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
- Recall number
- Z-0010-2013
- Recalling firm
- C.R. Bard, Inc., Urological Division
- 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 product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
- Status
- Terminated
- Initiated
- 2012-09-07
- Posted
- 2012-10-04
- Terminated
- 2013-03-21
- Reason
- 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.
- Root cause
- Employee error
- Action
- An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.
- Quantity
- 4,032 units
- Distribution
- Nationwide distribution: USA and Puerto Rico
- Lot, serial or model codes
- Catalog # 165808, Lot # NGWA1111
- 510(k) numbers
- ["K821745"]
- PMA numbers
- not on file
- Product code
- KOD
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28