Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1629-2023Class II

Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with...

Arjohuntleigh Magog, Inc. / initiated 2023-02-17 / Open, Classified / root cause: manufacturing process

Arjohuntleigh Magog, Inc. began a recall of Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment on . FDA classified it as Class II and gives the reason as "Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1629-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Arjohuntleigh Magog, Inc.
Product
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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 [email protected].
Quantity in commerce
3
Distribution
US: OH, NY
Product codes and lots
UDI/DI 05055982760713, Serial Numbers: 300501841, 300501842, 300515661

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1629-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1629-2023Class IIOngoingVoluntary: Firm initiated