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Class 2 Device Recall Spiralgold |
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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/ Manufacturer |
Jostra-Bentley Corporation 2828 North Cresent Ridge Dr The Woodlands 77381-3902
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Manufacturer Reason for Recall |
Separation between lid and housing unit.
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Action |
Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.
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Quantity in Commerce |
356 units |
Distribution |
OH, KY, AL, TN, FL, NY, IL, no government or military accounts |
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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.
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