| | Class 2 Device Recall NeatNick |  |
| Date Initiated by Firm | May 11, 2007 |
|---|
| Date Posted | June 09, 2007 |
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| 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/
Manufacturer |
Hawaii Medical LLC
750 Corporate Park
Pembroke MA 02359
|
| For Additional Information Contact | Read McCarty
781-826-5565 |
|---|
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 |
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FDA Determined
Cause 2 | Other |
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| Action | Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007. |
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| Quantity in Commerce | 286,376 units |
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| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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