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Terminated

OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels

FDA Recall Z-2835-2011 · Posted 2011-07-15

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeF
Date Initiated2011-05-27
Date Terminated2012-01-05
Product Quantity1,032,515 in US

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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