Reported Nov 25, 2015 · Terminated
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx…
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 Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Lot codes and dates
238 of 238 codes
M099850M102860M109690M116920M121840M145200M167240M177420M183850M187880M197330M198000M214900M223090M243020M259940M275080M299890M307610M323480M324340M336880M371260M388610M418830M468260M505290M508000M595790M610020M614660M619370M328280M347150M354390M359630M385190M397110M402790M444170M473920M477540M492030M499400M507160M513450M525040M541820M643750M030030M086380M091280M102870M111660M123680M126080M137910M140300M145210M157840
- Amount recalled
- 508 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.
Free recall alerts
Get alerted about new Civco Medical Instruments Co. Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.