Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0563-2019

November 02, 2018

Class II

Product summary

Firm
CIVCO Medical Instruments Co., Inc.
Event
Event 81361
Status
Terminated
Classification
Class II
Quantity
1,375 boxes
Official record key
device-enforcement:Z-0563-2019

Official wording

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

Code information: Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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