Reported Nov 25, 2015 · Terminated

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234,…

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 Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Lot codes and dates: 187 of 187 codes
M367350
M370110
M375100
M381740
M406940
M407750
M413300
M413310
M434210
M436400
M445180
M647110
M093610
M113720
M122370
M153900
M206940
M250330
M250340
M258890
M315660
M333490
M340650
M340660
M418340
M421310
M450400
M465510
M473820
M499620
M519670
M519870
M535840
M560410
M569020
M665970
M085160
M096150
M107000
M130450
M155430
M163490
M203230
M215600
M237160
M280540
M295050
M309920
M315640
M335660
M341050
M395150
M426910
M432250
M445050
M447240
M447250
M457880
M463120
M470960
Amount recalled: 717 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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