Recall Z-0926-2007 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Hawaii Medical LLC
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)
| Date | Jun 9, 2007 (initiated May 11, 2007) |
| Status | Terminated |
| Reason | 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 |
| 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 | 286,376 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.