Date Initiated by Firm |
September 13, 2005 |
Date Posted |
November 16, 2005 |
Recall Status1 |
Terminated 3 on October 03, 2006 |
Recall Number |
Z-0141-06 |
Recall Event ID |
33454 |
510(K)Number |
K021989
|
Product Classification |
Instrument, Ultrasonic Surgical - Product Code LFL
|
Product |
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set. |
Code Information |
Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215. |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
|
For Additional Information Contact |
Judith O'Grady 609-936-2311
|
Manufacturer Reason for Recall |
Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
|
FDA Determined Cause 2 |
Other |
Action |
FedEx packages were sent out to their customers 9/13/2005. |
Quantity in Commerce |
24 (four 1 packs)(four 5 packs) |
Distribution |
The product is distributed directly to the firm''s sales representatives and direct accounts. |
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.
|
510(K) Database |
510(K)s with Product Code = LFL and Original Applicant = INTEGRA NEUROSCIENCES
|