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
Enforcement
- Recall Number
- Z-0589-2019
- Event ID
- 81562
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 19, 2018
- Initiation Date
- October 22, 2018
- Classification Date
- December 7, 2018
- Termination Date
- May 19, 2021
- Address
- Ui. Ks. Piotra Wawrzyniaka 2, N/A, Komorniki, N/A, N/A, Poland
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
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.
Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
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