Reported Nov 25, 2015 · Terminated
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter)…
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
Is this the product you have?
- CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Lot codes and dates
M116270M119900M121920M125640M130290M170900M185950M204790M211280M215550M235410M240880M252870M303130M320620M320660M346050M368820M379870M391260M395270M418200M476020M497220M508200M594740M598320and M624430
- Amount recalled
- 54 boxes
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Sterility of the product cannot be assured.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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