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U.S. Department of Health and Human Services

Class 2 Device Recall NeatNick

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  Class 2 Device Recall NeatNick see related information
Date Initiated by Firm May 11, 2007
Date Posted June 09, 2007
Recall Status1 Terminated 3 on July 22, 2008
Recall Number Z-0926-2007
Recall Event ID 37984
Product Classification Heel Lancet - Product Code FMK
Product NeatNick Sweeping Action Heel Lancet -Full-Term-
Item Number: 1030085 (box of 100) and
Item Number: 1030086, case of 1,000 (10 boxes of 100)
Code Information M073010, M085019, M088037, M094012, M106010, M107016, M116013, M122004
Recalling Firm/
Hawaii Medical LLC
750 Corporate Park
Pembroke MA 02359
For Additional Information Contact Read McCarty
Manufacturer 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
FDA Determined
Cause 2
Action Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.
Quantity in Commerce 286,376 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.