• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Terumo see related information
Date Initiated by Firm July 26, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-0140-06
Recall Event ID 32923
510(K)Number K962981  
Product Classification Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type - Product Code KFM
Product Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump
The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows:
Convenience Kit Identifier Code/Kit Lot Numbers:
65077 FA17
62266-01 EP13
62266-01 FA31
63819-01 FC07
64034 FA03
64033 FD07
70131 FA03
70131 FA10
63607 FA31
63607 FD07
64091 FC07
64338 EP13
64338 FC07
70964 EP20
70964 FD07
70014-02 EP13
70014-02 FA03
70014-02 FC07
70014-02 FC07T
70014-02 FD07
70226-01 FD07
64987 FA24
64987 FD14
62933-01 FD14
62984-01 FA24
63004-01 FA03
63004-01 FA24
63361-01 EP27
63118 EP13
63118-01 FA24
63118-01 FC28
63118-01 FD14

Code Information Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14   
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact Brian Dawson
734-741-6066
Manufacturer Reason
for Recall
Small cracks in the blood chamber may allow air to enter the rotor of the device
FDA Determined
Cause 2
Other
Action Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product.
Quantity in Commerce 893 kits
Distribution AZ, CA, KY, IL, LA, MD, WA , WI
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 = KFM and Original Applicant = TERUMO MEDICAL CORP.
-
-