Class 2 Device Recall SwiftHook

• Date Initiated by Firm: August 21, 2020
• Create Date: October 09, 2020
• Recall Status: Terminated on January 30, 2023
• Recall Number: Z-0096-2021
• Recall Event ID: 86318
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: SwiftHook sold as the following:; a. Individually as SwiftHook; b. Included with Vega505EE mobile lifts; Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.
• Code Information: a. Model number: 70200008; b. Model number: 60600003; Serial Numbers 660311979, 660311759, 010733176902042221660312235, 660311299, 660312299 660311338, 7331769020422, 660311817,660311846, 660311847, 660311848, 6603118540422, 660311855, 6603118560422, 660311849, 660311850, 660311851, 660311852, 660311877, 660311878, 660311880, 660311941, 660311942, 660311968, sales order number 100931 (serial number could not be located)
• Recalling Firm/ Manufacturer: Handicare AB; Maskinvagen 17; Lulea Sweden
• Manufacturer Reason for Recall: Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
• FDA Determined Cause: Use error
• Action: Handicare USA issued an field safety notification on August 21, 2020. It states the following. Users of affected units are urgently requested to perform the following actions for devices in their possession without delay upon receiving the field notice. It is advised to cease using the Swifthook. Instead, the carry bar can be mounted directly onto the mobile or ceiling lift. This action will eliminate the possibility of incorrectly mounting the Swifthook while gaining the advantage of increased lift height capacity. The Swifthook should be destroyed. 1. Remove the Swifthook from the carry bar using the appropriate Allen key (5 mm) and wrench (13 mm); 2. Remove the fasteners from the mobile lift's boom using two 13 mm wrenches. In the case of a ceiling lift, remove the fasteners from the ceiling lift's H-adapter using two 4 mm Allen Keys; 3. Attach the carry bar directly to the mobile lift's boom. Check that the lock nuts are undamaged and still offers resistance to tightening by hand, and if not, replace with new nuts (DIN985 M8fzb lock nut). In the case of a ceiling lift, use two 4 mm Allen Keys and tighten well by hand. Each customer is required to communicate the content of the field safety notice to all end users and complete the response form, which shall be returned by email to Handicare USA using provided contact details no later than September 28, 2020. For any questions regarding this FSN, please contact FieldAction.NorthAmerica@handicare.com or Laren Mcintosh, Director of Quality, North America.
• Quantity in Commerce: 6716 units (585 in US; 6131 in OUS)
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, IL, MD, MI, MN, NH, NJ, NY, ON, PA, TX, VA, WA, WI and the countries of Australia, Belgium, Canada, Chile, Denmark, Finland, Germany, Iceland, Ireland, Israel, Japan, Lithuania/ Lathvia, Malaysia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Spain, Sweden, Taiwan the Netherlands, UAE, UK.
• 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.