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U.S. Department of Health and Human Services

Class 2 Device Recall CAPIOX Flexible Venous Reservoir

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  Class 2 Device Recall CAPIOX Flexible Venous Reservoir see related information
Date Initiated by Firm July 21, 2011
Date Posted August 04, 2011
Recall Status1 Terminated 3 on February 10, 2012
Recall Number Z-2950-2011
Recall Event ID 59454
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
Product CAPIOX¿ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921***

Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
Code Information CAPIOX Flexible Venous Reservoir, Lot NE13, (used as single units) or as a component in sterilized custom cardiovascular procedure kits with kit lot numbers NC21 R, ND21 R, NF02, and NF02.
Recalling Firm/
Terumo Cardiovascular Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information Contact Terumo Cardiovascular Systems
Manufacturer Reason
for Recall
Reservoir blood bag used in cardiovascular procedures may leak.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.
Quantity in Commerce 253 reservoirs
Distribution (USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.
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.