ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling — Class II medical device recall Z-0589-2019
Terminated recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., reported 2018-12-19, distributed nationwide. Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may b
| Recall number | Z-0589-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, N/A, Poland |
| Recall initiated | 2018-10-22 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2021-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 40679252100332 |
| Lot numbers | DHD1301721UPN |
| Model numbers | MFA1000M-L-L1 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0589-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.