FDA Medical Device Recalls (openFDA)
Bard Access Systems, Inc: Site-Rite Sterile Needle Guide Kit - 20 gauge
- Recall number
- Z-0715-05
- Recalling firm
- Bard Access Systems, Inc
- Product
- Site-Rite Sterile Needle Guide Kit - 20 gauge
- 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 needle guide 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
- 34,619 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 9001C0214. Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189, 63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402, 63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615, 63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957, 63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229, 64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460, 64493.
- 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