openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 8
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111034; Lot Number: A228672
Distribution pattern
US States: OH, PA, WA. China.
device · product 2 of 8
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111041; Lot Number: A228673
Distribution pattern
US States: OH, PA, WA. China.
device · product 3 of 8
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111072; Lot Number: A276634
Distribution pattern
US States: OH, PA, WA. China.
device · product 6 of 8
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111089; Lot Number: A276633
Distribution pattern
US States: OH, PA, WA. China.
device · product 7 of 8
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111096; Lot Number: A276636, A282454
Distribution pattern
US States: OH, PA, WA. China.
device · product 8 of 8
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
These labels are deterministic app interpretations, not FDA categories.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Code information
UDI-DI: 00841436111102; Lot Number: A257459, A252198, A268105, A276632
