Class 2 Device Recall OneTouch SureSoft Lancing Device

• Date Initiated by Firm: October 11, 2005
• Date Posted: December 08, 2005
• Recall Status: Terminated on November 21, 2006
• Recall Number: Z-0271-06
• Recall Event ID: 33941
• Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code NBW
• Product: LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
• Code Information: Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395. Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6301
• For Additional Information Contact: Healthcare Professional Line; 800-524-7226
• Manufacturer Reason for Recall: In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
• FDA Determined Cause: Other
• Action: On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
• Quantity in Commerce: 1123 boxes
• Distribution: Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the 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.