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 Spiralgold

  • 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 Recall Spiralgoldsee related information
Date Initiated by FirmNovember 01, 2002
Create DateDecember 02, 2002
Recall Status1 Completed
Recall NumberZ-0312-03
Recall Event ID 25002
ProductSpiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
Code Information Part Number C6918A4E (lots 63355 and 64015) Part Number C6918A3E (lots 63408, 63987, and 63988) Part Number C9315A2B (lot 63998) Part Number 60163301 (lot 64408, serial numbers starting with  7xxxxx)  
Recalling Firm/
Manufacturer		 Jostra-Bentley Corporation
2828 North Cresent Ridge Dr
The Woodlands 77381-3902
Manufacturer Reason
for Recall		Separation between lid and housing unit.
ActionAccounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.
Quantity in Commerce356 units
DistributionOH, KY, AL, TN, FL, NY, IL, no government or military accounts
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.
-
-