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.
FDA Recall Z-0842-2012 · Posted 2012-01-24
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Recalling FirmTerumo Cardiovascular Corporation
Recall StatusTerminated
Product CodeDTZ
Date Initiated2010-06-28
Date Terminated2012-02-29
Product Quantity16 units
Reason for Recall
Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including states of: WI, MO,and KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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