Arjo Portable Scale Adaptor…

Date

May 31, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Arjohuntleigh Magog, Inc.

Product

Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment

Reason

Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.

Distribution pattern

US: OH, NY

Quantity

3

Codes and lots

UDI/DI 05055982760713, Serial Numbers: 300501841, 300501842, 300515661

Recall started

Feb. 17, 2023

Device type

Lift, Patient, Non-Ac-Powered

Root cause (FDA)

Process control

What the company told customers

Arjo issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 02/17/2023 via letter, UPS, 2nd Day Delivery. The notice explained the problem, the risk, and requested the consignee remove the units from use and destroy them. The firm will be replacing the units upon receipt of the completed response form. For questions or assistance in completing the Customer Response Form, please contact Arjo at 1 800-323-1245 or via email at ArjoCustomer.Response-US@arjo.com.

Recall number

Z-1629-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1629-2023. The agency record governs; check it and the company before acting.