—#41081

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

FDA product code: KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K962981
Affected lot / code info: 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

Why it was recalled

Small cracks in the blood chamber may allow air to enter the rotor of the device

Root cause (FDA determination)

Other

Action the firm took

Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: AZ, CA, KY, IL, LA, MD, WA , WI

Timeline

Recall initiated: 2005-07-26
Posted by FDA: 2005-11-16
Terminated: 2006-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.