Date Initiated by Firm |
July 18, 2005 |
Date Posted |
August 06, 2005 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number |
Z-1106-05 |
Recall Event ID |
32798 |
PMA Number |
P000046 |
Product Classification |
Aid, Surgical, Viscoelastic - Product Code LZP
|
Product |
Staarvisic II Sodium Hyaluronate, 0.8 mL |
Code Information |
Lot B041118C Exp Date 12/31/2005 |
Recalling Firm/ Manufacturer |
Staar Surgical Co Inc 1911 Walker Ave Monrovia CA 91016-4846
|
For Additional Information Contact |
Valerie Cimmarusti 626-303-7902
|
Manufacturer Reason for Recall |
Sterility may be compromised.
|
FDA Determined Cause 2 |
Other |
Action |
Recall will be communicated by telephone, email and letter. A fax back form will be used to track response and to identify ammount on hand. |
Quantity in Commerce |
16,464 |
Distribution |
Nationwide, Canada and Puerto Rico |
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.
|
PMA Database |
PMAs with Product Code = LZP and Original Applicant = Anika Therapeutics, Inc.
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