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Terminated

Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.

FDA Recall Z-1729-2013 · Posted 2013-07-13

Recall StatusTerminated
Product CodeFMK
Date Initiated2013-07-03
Date Terminated2015-03-13
Product Quantity7, 712, 000 pieces (1928 cartons)

Reason for Recall

Lancets were not sterilized within the dose range established by sterilization validation.

Firm Action

The firm, KooJoo, sent a "MEDICAL DEVICE VOLUNTARY T RECALL" letter dated July 3, 2013 via first class mail to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to identify and hold all safety lancets you have in inventory that was received before June 2013; notify your retail customers of this product recall and complete and return the attached Customer Reply Form via email to [email protected] and also return form along with any unused/undistributed product for replacement. If you have further questions, please email [email protected] or call 209-403-9191 during 9:00am to 5:00pm M-F PST.

Root Cause

Process control

Distribution Pattern

US Distribution GA only.

Official Source

View FDA Recall →

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

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