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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch SureSoft Lancing Device

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  Class 2 Device Recall OneTouch SureSoft Lancing Device see related information
Date Initiated by Firm October 11, 2005
Date Posted December 08, 2005
Recall Status1 Terminated 3 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 2		 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.
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