Atlas FDA

NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,0

FDA device recall Z-0926-2007 · posted 2007-06-09 · Terminated

Recall details

Recalling firm
Hawaii Medical LLC
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
Action taken
Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.
Root cause
Other
Status
Terminated
Product code
FMK
Quantity affected
286,376 units
Distribution
Nationwide
Date initiated
2007-05-11
Date posted
2007-06-09
Date terminated
2008-07-22
Location
Pembroke, MA

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