Recall Z-0589-2019 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
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
| Date | Oct 22, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/10/2018 the firm informed its US consignee via telephone of an Urgent Medical Device Removal Action. On 11/10/2018, an Urgent Field Safety Notice Letter was sent via United Parcel Services (UPS) to consignees. The firm informed its consignee that according to inspection and test results at the manufacturer, it was found that nonwoven material used in this specific lot of the product might break on the main body while in use during the patient/resident transfer. If the product fails as described, the patient/resident might fall on the floor. In consequence, the patient might sustain a ma |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.