ARJOHUNTLEIGH POLSKA Sp. z.o.o.: Medical Device Recall in 2018 - (Recall #: Z-0589-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 22, 2018

Date Posted: December 19, 2018

Recall Number: Z-0589-2019

Event ID: 81562

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.

Status: Terminated

Product Quantity: 10

Code Information:

Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated