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Devices
Device Recall Terumo
Model / Serial
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
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
AZ, CA, KY, IL, LA, MD, WA , WI
Product Description
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
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
Recall of Device Recall Terumo
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Manufacturer
Terumo Cardiovascular Systems Corp
Manufacturer Address
Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
Source
USFDA
138 devices with a similar name
Learn more about the data
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Device Recall Terumo Custom Kit
Model / Serial
Lots: ME05, ME26, MF03
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution USA and Canada
Product Description
Terumo Cardiovascular Procedure Kit Custom || X-COATED HEART/LUNG FRAMEPACK || P/N 71766PP
Manufacturer
Terumo Cardiovascular Systems Corp
Device Recall Terumo Custom Kit
Model / Serial
Lots: ME19, ME19T, MF17
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution USA and Canada
Product Description
Terumo Cardiovascular Procedure Kit Custom || X-COATED PERFUSION PACK || P/N 71934
Manufacturer
Terumo Cardiovascular Systems Corp
Device Recall Terumo Weighted Flexible Sucker
Model / Serial
Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
Product Description
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Manufacturer
Terumo Cardiovascular Systems Corporation
Device Recall Terumo "Custom" Cardiovascular Procedure Kit
Model / Serial
Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
Product Description
Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113)
Manufacturer
Terumo Cardiovascular Systems Corp
Device Recall Terumo "Custom" Cardiovascular Procedure Kit
Model / Serial
Lot Numbers: GF08, GF30, GN06, HA15, HE09, HH02, HK27, HM01, HM22, HN12, HP17 and KA07.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
Product Description
Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)
Manufacturer
Terumo Cardiovascular Systems Corp
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