| Class 2 Device Recall | |
Date Initiated by Firm | March 28, 2005 |
Date Posted | April 27, 2005 |
Recall Status1 |
Terminated 3 on July 11, 2005 |
Recall Number | Z-0775-05 |
Recall Event ID |
31653 |
Product Classification |
Gauze/Sponge, Internal, X-Ray Detectable - Product Code GDY
|
Product | STAAR Phaco Tubing Kit |
Code Information |
Lot 08345 |
Recalling Firm/ Manufacturer |
Staar Surgical Co Inc 1911 Walker Ave Monrovia CA 91016-4846
|
For Additional Information Contact | Valerie Cimmarusti 626-303-7902 Ext. 2345 |
Manufacturer Reason for Recall | Complaints of leaking with question of sterility and risk of infection in eye. |
FDA Determined Cause 2 | Other |
Action | Recall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted. |
Quantity in Commerce | 114 |
Distribution | CA, NV, UT, FL, OR. |
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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