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Class 3 Device Recall OriGen |
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| Date Initiated by Firm |
December 16, 2002 |
| Date Posted |
October 15, 2005 |
| Recall Status1 |
Terminated 3 on November 03, 2005 |
| Recall Number |
Z-0055-06 |
| Recall Event ID |
31526 |
| Product Classification |
Catheter, Intravascular, Diagnostic - Product Code DQO
|
| Product |
Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744 |
| Code Information |
Model V V 12F; Lot Number 36BC20121 |
Recalling Firm/
Manufacturer |
Origen Biomedical, Inc
4020 S Industrial Dr Ste 160
Austin TX 78744-1080
|
Manufacturer Reason
for Recall |
Leak between two lumens causes reduced performance.
|
FDA Determined
Cause 2 |
Other |
| Action |
The recall was initiated by letter to all consignees on 12/16/2002. |
| Quantity in Commerce |
170 catheters |
| Distribution |
The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany. |
| 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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