Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1629-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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