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

FDA device recall Z-2835-2011 · posted 2011-07-15 · Terminated

Recall details

Recalling firm

Lifescan Inc

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.

Action taken

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

Status

Terminated

Product code

F

Quantity affected

1,032,515 in US

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2011-05-27

Date posted

2011-07-15

Date terminated

2012-01-05

Location

Milpitas, CA