FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
- Recall number
- Z-3226-2017
- Recalling firm
- C.R. Bard, Inc.
- Product
- Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
- Status
- Terminated
- Initiated
- 2017-07-28
- Posted
- not on file
- Terminated
- 2020-08-25
- Reason
- Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
- Root cause
- Employee error
- Action
- Customers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs.
- Quantity
- 45,270 units
- Distribution
- Distribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA.
- Lot, serial or model codes
- Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020
- 510(k) numbers
- ["K033477"]
- 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