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.
Reported: December 19, 2018 Initiated: November 2, 2018 #Z-0563-2019
Product Description
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.
Reason for Recall
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Details
- Recalling Firm
- CIVCO Medical Instruments Co., Inc.
- Units Affected
- 1,375 boxes
- 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.
- Location
- Coralville, IA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CIVCO Medical Instruments Co., Inc.. Units affected: 1,375 boxes.
Why was this product recalled? ▼
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0563-2019.
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