Class 2 Device Recall Flite Clip Sling, 4 Point

• Date Initiated by Firm: October 22, 2018
• Create Date: December 07, 2018
• Recall Status: Terminated on May 19, 2021
• Recall Number: Z-0589-2019
• Recall Event ID: 81562
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• 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
• Code Information: Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
• Recalling Firm/ Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.; Ui. Ks. Piotra Wawrzyniaka 2; Komorniki Poland
• For Additional Information Contact: Carmen Swanson; 210-452-1837
• Manufacturer 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.
• FDA Determined 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 major trauma, head injury - damage to tissue that is irreversible or may lead to death. The notification also instructed the consignee to distributed to those individuals who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to contact the firm if potentially affected products were found. Customers were also instructed to maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. If you have any further questions or require assistance completing the Customer Response Form, please contact Arjo via email at ArjoCustomer.Response-US@Arjo.com. In addition to the notification, a Customer Response Attestation requiring customers to complete the form and return via email to arjocustomer.response-us@arjo.com or fax to 1-833-fax-arjo.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.