Z-0716-05

Site-Rite Sterile Needle Guide Kit - 21 Gauge

Name: Z-0716-05 Site-Rite Sterile Needle Guide Kit - 21 Gauge
Creator: Bard Access Systems, Inc
Published: 2004-11-03
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2004-11-03 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems, Inc began a recall of Site-Rite Sterile Needle Guide Kit - 21 Gauge on 2004-11-03. The reason FDA records is "Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0716-05
Status: Terminated
Initiated: 2004-11-03
Posted: 2005-04-22
Terminated: 2005-04-22
Recalling firm: Bard Access Systems, Inc.
Product: Site-Rite Sterile Needle Guide Kit - 21 Gauge
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Root cause tag: labeling and UDI
FDA 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 in commerce: 27,721 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.
Product codes and lots: Product Code 90013B01. Lot Numbers 61189, 61219, 61280, 61302, 61332, 63141, 63147, 63171, 63245, 63262, 63339, 63360, 63401, 63421, 63422, 63450, 63451, 63521, 63538, 63590, 63615, 63666, 63723, 63729, 63770, 63814, 63830, 63862, 63913, 63925, 63991, 63998, 64028, 64063, 64080, 64137, 64151, 64192, 64218, 64229, 64261, 64289, 64330, 64353, 64375, 64401, 64447, 64492, 64550, 64591.

Product code ITX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)