Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1729-2013 — 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

U.S. FDA — Device Enforcement · Korea, Republic Of (South) · 2013-07-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1729-2013
Date of alert: 2013-07-03
Country / jurisdiction: Korea, Republic Of (South)
Risk level: Class II
Risk type: recall
Brand: KooJoo Trading Company
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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