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U.S. Department of Health and Human Services

Class 2 Device Recall Century Console Base

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 Class 2 Recall
Century Console Base
see related information
Date Posted March 01, 2013
Recall Status1 Terminated on April 15, 2013
Recall Number Z-0902-2013
Recall Event ID 64383
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
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, Arizona 85201-6924
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.
FDA Determined
Cause 2
PREMARKET APPROVAL: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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