Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Ca...
FDA Device Recall #Z-0014-2018 — Class II — July 28, 2016
Recall Summary
| Recall Number | Z-0014-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 28, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Handicare AB |
| Location | Lulea |
| Product Type | Devices |
| Quantity | 9 units |
Product Description
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Reason for Recall
A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.
Distribution Pattern
OH, PA, MD
Lot / Code Information
a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160 b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584 c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571
Other Recalls from Handicare AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0096-2021 | Class II | SwiftHook sold as the following: a. Individual... | Aug 21, 2020 |
| Z-1943-2020 | Class II | EVA Floor Lifts, Model Numbers: 400, 450, 600 | Jun 15, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.