FDA-Device2018-12-19Class II
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.
CIVCO Medical Instruments Co., Inc.
Hazard
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Sold states
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.
Affected count
1,375 boxes
Manufactured in
2301 Jones Blvd, N/A, Coralville, IA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2019Don't want to check this manually?
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