medical Class II Updated 2018-12-19

CIVCO Medical Instruments Co., Inc. recalls CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-ster

Recalled Product

CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.


Hazard / Issue

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

Issued by

FDA

Distribution: 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.
Lot/Code Info: Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.
View official government recall

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