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U.S. Department of Health and Human Services

Class 3 Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell Reservoir

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  Class 3 Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell Reservoir see related information
Date Initiated by Firm June 28, 2010
Date Posted January 24, 2012
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0842-2012
Recall Event ID 60475
510(K)Number K993772  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 ¿. 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.
Code Information Product code 3CXSX18RX, Lot # HF22
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information Contact Michael Silvestri
410-392-7102
Manufacturer Reason
for Recall		 Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
FDA Determined
Cause 2		 Employee error
Action All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed "Urgent Medical Device Removal " letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.
Quantity in Commerce 16 units
Distribution Nationwide Distribution including states of: WI, MO,and KY.
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 = DTZ and Original Applicant = TERUMO MEDICAL CORP.
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