ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intende…

Recall date

October 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0589-2019

FDA classification

Class II

Brand / firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Sold / distributed

US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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