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.
FDA Recall Z-2888-2018 · Posted None
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Recalling FirmCivco Medical Instruments Co. Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2018-02-23
Date Terminated2020-10-06
Product Quantity177 boxes
Reason for Recall
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Firm Action
Telephone Script to be read:
CIVCO is calling to notify our customers regarding a recall action being initiated.
CIVCO has recently discovered a dimensional issue in our Infiniti bracket which may allow the needle guide to a puncture a cover. You are being notified, as your facility has been identified as having received product from one of the affected manufacturing lots.
Advise on Action to be taken by Customer or Distributor:
To return Infiniti needle guide, contact your Account Representative at 800-445-6741 or 319-248-6757. Alternately you may also use email at [email protected] to schedule the return of your device.
Additional information to obtain:
Verification of Email contact to send notification letter and response letter.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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