Class 2 Device Recall PRISM MEDICAL A625

• Date Initiated by Firm: September 08, 2017
• Date Posted: September 15, 2017
• Recall Status: Terminated on December 17, 2018
• Recall Number: Z-0013-2018
• Recall Event ID: 78096
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
• Code Information: A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498
• Recalling Firm/ Manufacturer: Handicare Usa Inc; 10888 Metro Ct; Maryland Heights MO 63043-2413
• For Additional Information Contact: 866-891-6502
• Manufacturer Reason for Recall: During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.
• FDA Determined Cause: Component design/selection
• Action: The firm initiated their recall by email on 09/08/2017. The consignee was warned that the lift straps may wear prematurely and they would be contacted by a representative and the units would be replaced.
• Quantity in Commerce: 8 units
• Distribution: Us and Canada
• 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.