FDA Recall Terminated

Drop Arm Versamode"

Recall: Z-1353-2021 · Initiated March 24, 2021

Recall

Recall Number
Z-1353-2021
Event Number
87606
Firm
Gf Health Products
FEI Number
2427360
Product Code
ILS
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
March 24, 2021
Terminated
May 1, 2023
Address
1 Graham Field Way, Atlanta, GA, 30360-2808

Description

Drop Arm Versamode"

Reason

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

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."

Distribution

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

Quantity

66 units