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U.S. Department of Health and Human Services

Class 2 Device Recall Spiralgold

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  Class 2 Device Recall Spiralgold see related information
Date Initiated by Firm November 01, 2002
Create Date December 02, 2002
Recall Status1 Completed
Recall Number Z-0312-03
Recall Event ID 25002
Product Spiral 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/
Jostra-Bentley Corporation
2828 North Cresent Ridge Dr
The Woodlands 77381-3902
Manufacturer Reason
for Recall
Separation between lid and housing unit.
Action Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.
Quantity in Commerce 356 units
Distribution OH, 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.