Class 2 Device Recall Molift 205, Molift 180, Molift Air

• Date Initiated by Firm: February 04, 2019
• Create Date: May 16, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1352-2019
• Recall Event ID: 81977
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
• Code Information: All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.
• FEI Number: 3004137175
• Recalling Firm/ Manufacturer: Moller Vital; Hadelandsvegen 2; P.o. Box 408; Gjovik Norway
• Manufacturer Reason for Recall: The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
• FDA Determined Cause: Use error
• Action: On February 4, 2019, the firm notified customers of the recall via Urgent Field Safety Notice letter. The letter alerted customers to the recalled product. The firm stated that all new 2-Point Sling Bars are now equipped with metal alloy hooks instead of the previously used composite hooks. As part of this recall, the firm will replace the recalled devices with the new design. Distributors were asked to do the following: 1) Read the instructions, and complete and return the customer response form 2) Notify affected customers of the recall 3) Review the list of sales records from Etac Supply Gjvik and supply additional information from your records. 4) Identify and contact end-customers/users and decide the requirement for ordering new units 5) Order new 2-Point Sling Bars from Etac Supply Gjvik 6) Ship replacement units to end customers accompanied by replacement instructions (see user manual) and the Consignee Form. The End-User/Customer must perform the replacement and fill the replacement records (green fields) in the consignee form and return a signed copy to the distributor. 7) Receive the signed Consignee Form from end-users/customers. Perform weekly reporting to Etac Supply Gjvik in the same spreadsheet that contains the sales records. The signed Consignee Forms must be returned to Etac Supply Gjvik as a complete package upon finalizing all replacements.
• Quantity in Commerce: 427 (total)
• Distribution: Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin. Foreign distribution to Canada, Asia, Europe, and Australia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.