FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
- Recall number
- Z-0314-04
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Product
- Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
- Status
- Terminated
- Initiated
- 2003-12-22
- Posted
- 2004-01-09
- Terminated
- 2004-09-01
- Reason
- Product packaging may contain holes compromising sterility.
- Root cause
- Other
- Action
- Consignees were notified by certified letter on 12/22/2003.
- Quantity
- 12,684 units (total includes both types)
- Distribution
- Product was distributed Nationwide, Canada, Belgium and Japan
- Lot, serial or model codes
- Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FFL
- 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