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Terminated

Drop Arm Versamode"

FDA Recall Z-1353-2021 · Posted None

Recalling FirmGf Health Products
Recall StatusTerminated
Product CodeILS
Date Initiated2021-03-24
Date Terminated2023-05-01
Product Quantity66 units

Reason for Recall

The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

Firm Action

A Recall notification letter titled, "URGENT CORRECTION AND REMOVAL" was sent to consignees on 03/24/2021 via FedEx priority. The consignees were instructed to: "The replacement of the front casters is required to ensure proper operation of the Versamode, and to eliminate any potential safety concern. 1. Contact GF Health Products at 1-888-974-4347 or [email protected] within ten (10) business days from receipt of this notification to schedule your front caster replacement order. Replacement front casters will be provided at NO CHARGE for Versamodes with lot number BMW316BS. 2. Upon receipt of the replacement casters, follow the enclosed instructions Replacing Your Lumex Drop Arm Versamode Front Casters. (Attachment 1) 3. Dispose of the incorrect, replaced casters in accordance with Federal, State, or Local regulations. 4. Fill out and sign the Certification of Replacement Agreement. (Attachment 2) 5. Return the completed Certification of Replacement Agreement to: [email protected] or Fax: 770-368-3333."

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.

Official Source

View FDA Recall →

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

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