| |
Class 2 Device Recall NeatNick |
 |
| 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/
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
|
FDA Determined
Cause 2 |
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 |
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.
|
|
|
|
