| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
March 04, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on January 04, 2005 |
| Recall Number |
Z-0730-04 |
| Recall Event ID |
28525 |
| 510(K)Number |
K023381
|
| Product Classification |
Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
|
| Product |
Vision Hollow Fiber Oxygenator with GBS Coating |
| Code Information |
Various |
Recalling Firm/
Manufacturer |
Gish Biomedical Inc
22942 Arroyo Vis
Rancho Santa Margarita CA 92688-2600
|
| For Additional Information Contact |
E. F. Waddell
949-635-6200
|
Manufacturer Reason
for Recall |
Customers reported leakage.
|
FDA Determined
Cause 2 |
Other |
| Action |
Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested. |
| Quantity in Commerce |
950 |
| Distribution |
NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA |
| 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 = DTZ and Original Applicant = GISH BIOMEDICAL, INC.
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