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 ha
Check against the official notice below — it lists the full affected range.
ArjoHuntleigh Polska is recalling the Arjo Passive Clip Sling, a device used to assist in transferring patients and residents. During the manufacturer's inspection process, it was discovered that specific product lots were made with nonwoven material that may break during use. If the sling breaks while transferring a patient, the patient could fall to the floor and sustain serious injuries including major trauma, head injury, or irreversible tissue damage that could result in death.
The recall affects 10 units of the Arjo Passive Clip Sling Model MFA1000M-L-L1, Lot DHD1301721, UPN 40679252100332, which were distributed nationwide in West Virginia. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US Quantity: 10 Lot/code info: Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.