FDA-Device2018-12-19Class II
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
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Hazard
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.
Sold states
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Affected count
10
Manufactured in
Ui. Ks. Piotra Wawrzyniaka 2, N/A, Komorniki, N/A, Poland
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. 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2019Don't want to check this manually?
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