Class 2 Device Recall One Touch SureSoft Lancing Device

• Date Initiated by Firm: March 30, 2007
• Date Posted: August 16, 2007
• Recall Status: Terminated on December 03, 2007
• Recall Number: Z-1165-2007
• Recall Event ID: 38035
• Product Classification: Lancing Device - Product Code FMK
• Product: One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
• Code Information: Lot SA4426; Part number 021-140-01
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6312
• For Additional Information Contact: 408-942-5903
• Manufacturer Reason for Recall: Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.
• Quantity in Commerce: 632 cartons (200 units per carton)
• Distribution: Product was distributed nationwide to distributors and wholesale dealers.
• 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.