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ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intend
Recalled December 19, 2018 · FDA recall Z-0589-2019 · 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. · FDA Class II
Units
10
Sold at
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Description
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.
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
Manufacturer(s)
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Made in
Poland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →