87 results
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Sources: EU EUDAMED, US FDA
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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.
FDA Recall
Terminated
·Terumo Cardiovascular Corporation·Product code DTN·July 21, 2011
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTN·May 9, 2003
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·March 3, 2016
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·February 4, 2021
Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·October 1, 2007
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·January 16, 2018
BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·February 4, 2021
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·June 3, 2009
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·September 22, 2017
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·September 22, 2017
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·February 4, 2021