FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
- Recall number
- Z-1357-2016
- Recalling firm
- C.R. Bard, Inc.
- Product
- BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
- Status
- Terminated
- Initiated
- 2015-12-18
- Posted
- not on file
- Terminated
- 2016-06-29
- Reason
- Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
- Root cause
- Error in labeling
- Action
- C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.
- Quantity
- 1,428,000 units (total)
- Distribution
- Distributed US (nationwide) and the countries of Canada and Australia.
- Lot, serial or model codes
- Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MJC
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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