PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 19, 2018 Initiated: October 22, 2018 #Z-0589-2019

Product Description

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 for Recall

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.

Details

Units Affected
10
Distribution
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Location
Komorniki, N/A

Frequently Asked Questions

What product 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. Recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o.. Units affected: 10.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0589-2019.

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