Reported Dec 19, 2018 · Terminated
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket…
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. · 2301 Jones Blvd · Coralville, IA · 52241-3469
Is this the product you have?
- CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
- Lot codes and dates
- Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.
- Amount recalled
- 738 boxes
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Why it was recalled
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
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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