FDA Medical Device Recalls (openFDA)
Bard Access Systems: Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.
- Recall number
- Z-0861-2010
- Recalling firm
- Bard Access Systems
- Product
- Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.
- Status
- Terminated
- Initiated
- 2010-01-14
- Posted
- 2010-02-26
- Terminated
- 2010-05-14
- Reason
- After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
- Root cause
- Component change control
- Action
- Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.
- Quantity
- 4,975 units
- Distribution
- Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
- Lot, serial or model codes
- Lot Numbers: RETK0229, RETJ0655.
- 510(k) numbers
- ["K993848"]
- PMA numbers
- not on file
- Product code
- FPA
- 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