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Terminated

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 to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.

FDA Recall Z-0777-2019 · Posted None

Recalling FirmRiverpoint Medical, LLC
Recall StatusTerminated
Product CodeIWJ
Date Initiated2018-01-09
Date Terminated2019-04-15
Product Quantity443 devices

Reason for Recall

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

Firm Action

The firm initiated the recall by telephone following with an email and letter on 01/09/02019 The firm requested the return of the recalled product.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide Distribution in the states of IL, WA, and FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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