Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)

FDA Recall Z-0927-2007 · Posted 2007-06-09

Recalling FirmHawaii Medical LLC
Recall StatusTerminated
Product CodeFMK
Date Initiated2007-05-11
Date Terminated2008-07-22
Product Quantity58,058 units

Reason for Recall

Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient

Firm Action

Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

↑