Drug recall
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a…
FDA recall event 81562 · Class II · ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Key facts
| Event ID | 81562 |
|---|---|
| Recall numbers | Z-0589-2019 |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 22, 2018 |
| Report date | Dec 19, 2018 |
| Termination date | May 19, 2021 |
| City | Komorniki |
| Country | Poland |
| FEI number | 3007420694 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: