medical Class II Updated 2018-12-19

ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Pr

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
View official government recall

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