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CIVCO Medical Instruments Co., Inc. recalls SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122
Recalled December 19, 2018 · FDA recall Z-0563-2019 · CIVCO Medical Instruments
Hazard
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. · FDA Class II
Units
1,375 boxes
Sold at
Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
Description
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Product
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
Manufacturer(s)
CIVCO Medical Instruments Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →