Reported Nov 25, 2015 · Terminated

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16,…

Civco Medical Instruments Co. Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Civco Medical Instruments Co. Inc. · 102 1st St S · Kalona, IA · 52247-9589

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Lot codes and dates: M093630
M093640
M093650
M128890
M128930
M163120
M191470
M191880
M202970
M205490
M211000
M218540
M218550
M218560
M240080
M250210
M262470
M308100
M328800
M333890
M371670
M384130
M396710
M399210
M399320
M399340
M403640
M412450
M421190
M423310
M424480
M451230
M457640
M461290
M468590
M470900
M473810
M487020
M511040
M545900
M545910
M547320
M560870
M570280
M570290
M585600
M585610
M586670
M594480
M600470
M609760
M611000
M632640
and M643150
Amount recalled: 206 boxes

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Sterility of the product cannot be assured.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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