Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2888-2018 — 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

U.S. FDA — Device Enforcement · United States · 2018-02-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2888-2018
Date of alert: 2018-02-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Civco Medical Instruments Co. Inc.
Product category: device
Product type: Devices

Reported risk: A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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