Z-0927-2007

NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084...

Name: Z-0927-2007 NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084...
Creator: Hawaii Medical LLC
Published: 2007-05-11
License: https://open.fda.gov/license/

Hawaii Medical LLC / initiated 2007-05-11 / Terminated

FDA source

Hawaii Medical LLC began a recall of NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100) on 2007-05-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0927-2007
Status: Terminated
Initiated: 2007-05-11
Posted: 2007-06-09
Terminated: 2008-07-22
Recalling firm: Hawaii Medical LLC
Product: NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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 root cause: Other
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: 58,058 units
Distribution: Nationwide
Product codes and lots: Lot Number: M095007, M066008

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)