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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 31, 2003
Date PostedApril 22, 2003
Recall Status1 Terminated 3 on March 09, 2004
Recall NumberZ-0780-03
Recall Event ID 26039
510(K)NumberK961530 
ProductVision Hollow Fiber Oxygenator
Code Information Lot 205200
FEI Number 2021836
Recalling Firm/
Manufacturer		 Gish Biomedical Inc
22942 Arroyo Vista
Rancho Santa Margarita CA 92688
For Additional Information ContactEdward F. Waddell
949-635-6200
Manufacturer Reason
for Recall		Two reports of leakage.
FDA Determined
Cause 2		Other
ActionThe firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
Quantity in Commerce1749
DistributionNationwide, Austria, Canada, Japan, Saudi Arabia
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) Database510(K)s with Product Code =
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