FDA Medical Device Recalls (openFDA)
Bard Access Systems, Inc: Intraoperative Ultrasound Cover Kit
- Recall number
- Z-0718-05
- Recalling firm
- Bard Access Systems, Inc
- Product
- Intraoperative Ultrasound Cover Kit
- Status
- Terminated
- Initiated
- 2004-11-03
- Posted
- 2005-04-22
- Terminated
- 2005-04-22
- Reason
- Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile.
- Root cause
- Other
- Action
- All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
- Quantity
- 8,561 units
- Distribution
- Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.
- Lot, serial or model codes
- Product Code 900023B01. Lot numbers 61233, 63200, 63235, 63263, 63270, 63324, 63357, 63375, 63401, 63409, 63414, 63451, 63458, 63515, 63530, 63559, 63612, 63615, 63646, 63674, 63770, 63824, 63875, 63953, 63998, 64080, 64191, 64258, 64269, 64289, 64317, 64493, 64586, 64646.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- 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