Reported Nov 25, 2015 · Terminated
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY.…
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 Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Lot codes and dates
346 of 346 codes
M475840M475850M483080M184760M201120M201220M201230M229890M230450M248410M265470M282270M307490M322230M367370M370090M381360M421260M431550M452150M458370M488300M514070M572510M576810M606320M626250M639290M642350M648020M540640M543800M551990M592190M604120M448100M477600M477700M504340M504350M507520M524270M544100M569330M569340M590710M600460M632390M643140M604180M091360M109060M122250M186540M202260M253050M275630M308820M335740M425050
- Amount recalled
- 1139 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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