Home / Recalls / Medical Devices
CIVCO Medical Instruments Co., Inc. recalls CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket
Recalled December 19, 2018 · FDA recall Z-0562-2019 · 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
738 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
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.
Manufacturer(s)
CIVCO Medical Instruments Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →