Recall Z-1353-2021 ยท ILS Adaptor, Hygiene
Gf Health Products
Drop Arm Versamode"
| Date | Mar 24, 2021 |
| Status | Terminated |
| Reason | The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. |
| Root cause | Nonconforming Material/Component |
| 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 fieldcorrection@grahamfield.com 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. |
| Quantity | 66 units |
| Distribution | Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.