Z-0861-2010

Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO...

Name: Z-0861-2010 Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO...
Creator: Bard Access Systems
Published: 2010-01-14
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2010-01-14 / Terminated

FDA source

Bard Access Systems began a recall of 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... on 2010-01-14. The reason FDA records is "After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0861-2010
Status: Terminated
Initiated: 2010-01-14
Posted: 2010-02-26
Terminated: 2010-05-14
Recalling firm: Bard Access Systems, Inc.
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
FDA 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 in commerce: 4,975 units
Distribution: Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
Product codes and lots: Lot Numbers: RETK0229, RETJ0655.

Product code FPA

K993848Class IIMillennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. / cleared 2000-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)