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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch Delica Lancing Device

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  Class 2 Device Recall OneTouch Delica Lancing Device see related information
Date Initiated by Firm May 27, 2011
Date Posted July 15, 2011
Recall Status1 Terminated 3 on January 05, 2012
Recall Number Z-2835-2011
Recall Event ID 59078
Product Classification Lancet, blood - Product Code F MK
Product OneTouch Delica Lancing Device;
LifeScan Inc., Milpitas, CA

Testing of Blood Glucose Levels
Code Information Model Number 022-137-01
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035
For Additional Information Contact Jon Mulberg
408-942-5937
Manufacturer Reason
for Recall		 Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
FDA Determined
Cause 2		 Other
Action Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.
Quantity in Commerce 1,032,515 in US
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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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