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Class 2 Device Recall Century Console Base |
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Date Initiated by Firm |
January 31, 2013 |
Date Posted |
March 01, 2013 |
Recall Status1 |
Terminated 3 on April 15, 2013 |
Recall Number |
Z-0902-2013 |
Recall Event ID |
64383 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product |
Century Console Base, Model #043625051b.
Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. |
Code Information |
Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144. |
Recalling Firm/ Manufacturer |
Salyer Prn Biomedical 1833 W Main St Ste 116 Mesa AZ 85201-6924
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Manufacturer Reason for Recall |
Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
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FDA Determined Cause 2 |
No Marketing Application |
Action |
An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232. |
Quantity in Commerce |
9 units |
Distribution |
Distributed in the states of MA,CA, and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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.
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