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Terminated

Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

FDA Recall Z-1208-2007 · Posted 2007-09-01

Recalling FirmAvazzia, Inc
Recall StatusTerminated
Product CodeGZJ
Date Initiated2007-06-29
Date Terminated2008-04-04
Product Quantity8 units

Reason for Recall

Plastic Cases may crack due to manufacturing by the supplier not meeting specifications

Firm Action

Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement.

Root Cause

Other

Distribution Pattern

Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062641BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1Avazzia, Inc. · 2007-04-30

Official Source

View FDA Recall →

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

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