Date Initiated by Firm |
January 30, 2007 |
Date Posted |
April 07, 2007 |
Recall Status1 |
Terminated 3 on November 28, 2007 |
Recall Number |
Z-0723-2007 |
Recall Event ID |
37383 |
Product Classification |
Disposable Precision Tips - Product Code -JTC
|
Product |
Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada |
Code Information |
Lot: 33906 P5 and Lot: 63906 P5 |
Recalling Firm/ Manufacturer |
Hamilton Co 4970 Energy Way Reno NV 89502-4123
|
Manufacturer Reason for Recall |
Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting.
|
FDA Determined Cause 2 |
Other |
Action |
The firm initiated its recall on January 30, 2007. The initial notification was sent via certified mail and e-mail. Subrecalls will be conducted by the distributor. |
Quantity in Commerce |
37 cases |
Distribution |
Nationwide (via a single distributor in New Jersey) |
|
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.
|