CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Reported: August 29, 2018 Initiated: February 23, 2018 #Z-2888-2018
Product Description
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Reason for Recall
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Details
- Recalling Firm
- Civco Medical Instruments Co. Inc.
- Units Affected
- 177 boxes
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
- Location
- Kalona, IA
Frequently Asked Questions
What product was recalled? ▼
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.. Recalled by Civco Medical Instruments Co. Inc.. Units affected: 177 boxes.
Why was this product recalled? ▼
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2888-2018.
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