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U.S. Department of Health and Human Services

Class 2 Device Recall CAPIOX FX25

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 Class 2 Device Recall CAPIOX FX25see related information
Date Initiated by FirmMarch 01, 2023
Date PostedApril 05, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1347-2023
Recall Event ID 91775
510(K)NumberK151791 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductCAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Code Information UDI-DI: (01)00699753450868; Lot Number AM03
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information ContactTerumo CVS Customer Service
800-521-2818
Manufacturer Reason
for Recall		Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
FDA Determined
Cause 2		Process control
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers. RECOMMENDED ACTIONS Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Terumo CVS will credit the user s accounts for returned, unused products. AFFECTED POPULATION The affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used. CUSTOMER INSTRUCTIONS - Review this Medical Device Recall notice and ensure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product inventory that is subject to this action. Confirm receipt of this communication by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Please return the Customer Response Form even if you no longer have the affected product in inventory. If the affected product has been distributed to another user or location, please forward a copy of the notice as needed. Terumo CVS will issue a Return Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 443-993-5738 or emailing 4439935738@efax.com Terumo Recall Email: TCVSCustomerResponseElkton@terumomedical.com
Quantity in Commerce4940 units
DistributionUS Nationwide. Belgium, Canada, Costa Rica, Thailand.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DTZ
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