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

Recall Z-0777-2019 — RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient

U.S. FDA — Device Enforcement · United States · 2018-01-09 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0777-2019
Date of alert: 2018-01-09
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Riverpoint Medical, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 18061816

Reported risk: Product is labeled with "CE", but is not yet approved in the European Union.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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