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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 500 Monitor

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  Class 2 Device Recall CDI 500 Monitor see related information
Date Initiated by Firm September 23, 2011
Date Posted October 31, 2011
Recall Status1 Terminated 3 on April 11, 2013
Recall Number Z-0142-2012
Recall Event ID 59582
510(K)Number K972962  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.
Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe.
Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and
Catalog 500A, CDI 500 Monitor with Arterial blood parameter module.

Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code Information Catalog # 500AVHCT, CDI Blood Parameter Monitoring Systerm 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe; serial numbers 1038,1217,1381,1459,1461, 2515, 3022, 3446, 4043, 4260, 5048-5056, 5065-5077, 5082-5085,5094-5101,5118-5125,5142-5149,5158-5169, 5178, 5179, 5190,5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253,5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344,5354-5356,5370-5374, 5383, 5385, 5386, 5516-5521, and 5537-5541.  Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Serial numbers 1258, 1361, 1518, 1571, 1636, 1690,1717,1775,1875,1882, 2026,2292,2413,2459,2832, 2984,3092,3256,3313,3432, 3527, 3633, 3660, 3790, 3825, 4104, 5040-5047, 5057-5064, 5078-5081,5086-5093,5102-5117, 5126-5141, 5150-5157, 5170-5177,5180-5189,5191-5196, 5199-5209,5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281,5286-5289, 5294-5297,5306-5317,5322- 5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5529, 5531,5542,5543,and 5546-5556  Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules. Serial numbers 0033, 0051, 1465, 5330, 5331, 5332, 5333, 5338, 5339, and 5340.  Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Serial numbers 1560 and 5349.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.
FDA Determined
Cause 2		 Component design/selection
Action Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.
Quantity in Commerce 432
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DRY and Original Applicant = 3M COMPANY
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