Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 04, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-0730-04
Recall Event ID 28525
510(K)NumberK023381 
Product Classification Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
ProductVision Hollow Fiber Oxygenator with GBS Coating
Code Information Various
FEI Number 2021836
Recalling Firm/
Manufacturer		 Gish Biomedical Inc
22942 Arroyo Vis
Rancho Santa Margarita CA 92688-2600
For Additional Information ContactE. F. Waddell
949-635-6200
Manufacturer Reason
for Recall		Customers reported leakage.
FDA Determined
Cause 2		Other
ActionFirm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.
Quantity in Commerce950
DistributionNY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTZ
-
-