Recall Z-0589-2019— ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class II · Terminated
Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2018-10-22, terminated 2021-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-22
- Terminated
- 2021-05-19
- Firm location
- Komorniki, N/A, Poland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.