FDA Device recall Z-0589-2019
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted trans…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted trans… by Arjohuntleigh Polska Sp Z O O, citing 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/reside….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0589-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-22 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arjohuntleigh Polska Sp Z O O |
| Distribution | US |
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
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.
Identifiers
| code_info | Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Arjohuntleigh Polska Sp Z O O
- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Device · Class II · 2026-04-22 · Arjohuntleigh Polska Sp Z O O - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - Sara Plus Active Floor Lift
FDA Device · Class I · 2022-06-01 · Arjohuntleigh Polska Sp Z O O - Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0
FDA Device · Class II · 2021-10-06 · Arjohuntleigh Polska Sp Z O O
All Arjohuntleigh Polska Sp Z O O recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.