ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sl...
FDA Device Recall #Z-0589-2019 — Class II — October 22, 2018
Recall Summary
| Recall Number | Z-0589-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 22, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Location | Komorniki, N/A |
| Product Type | Devices |
| Quantity | 10 |
Product Description
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver with everyday patient handling routines, such as bed and chair related transfers. REF MFA1000M-L-L1 RM0255_7
Reason for Recall
Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might fall on the floor. IN consequence, the patient might sustain a major trauma, head injury - damage to tissue that is irreversible or may lead to death.
Distribution Pattern
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Lot / Code Information
Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
Other Recalls from ARJOHUNTLEIGH POLSKA Sp. z.o.o.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0611-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Ent... | Aug 29, 2023 |
| Z-0612-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Ent... | Aug 29, 2023 |
| Z-1098-2022 | Class I | Sara Plus Active Floor Lift | Apr 5, 2022 |
| Z-2588-2021 | Class II | Arjo Citadel beds originally assembled with the... | Jun 10, 2021 |
| Z-2821-2020 | Class II | Bariatric Bed Frame System The Citadel Plus ... | Jul 21, 2020 |
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.