ClearanceBrief
Panels › General Hospital › Product code BRZ · Class 2

Set, Blood Transfusion

Regulation 880.5440

0510(k)s in 12 months (30 all time)
0recalls in 12 months (24 all time)
23recalls that name a 510(k)
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Top companies in BRZ

Company510(k)sRecalls
Hospira Inc.013
Baxter Healthcare Corp38
Genesis BPS, LLC.03
The Boston Medical Group20
Puritas Health Care, Inc.20
Alpha Therapeutic Corp.10
Amkor Trading Co.10
Arteriocyte Medical Systems, Inc.10
Blood Products Specialties, LLC10
Cardinal Health, Alaris Products10
DateFirm and productCodeLinked 510(k)
Sep 18, 2014Genesis BPS, LLC.
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and
Terminated
BRZK050805
Sep 18, 2014Genesis BPS, LLC.
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platel
Terminated
BRZK050805
Sep 18, 2014Genesis BPS, LLC.
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plas
Terminated
BRZK050805
Aug 5, 2013Hospira Inc.
List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be di
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to H
Terminated
BRZK103224
Aug 5, 2013Hospira Inc.
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc.,
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Ri
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 6004
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries sh
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045
Terminated
BRZK101677
Aug 5, 2013Hospira Inc.
List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest
Terminated
BRZK101677
Nov 24, 2005Hospira Inc.
LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration s
Terminated
BRZK830014
K920736 +1
Nov 15, 2005Hospira Inc.
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; Hospira, Inc
Terminated
BRZK830014
K865060 +2
Nov 15, 2005Hospira Inc.
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; Hos
Terminated
BRZK830014
K865060 +2
Nov 15, 2005Hospira Inc.
LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 6004
Terminated
BRZK830014
K865060 +2
Aug 21, 2003Baxter Healthcare Corp.
Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C7784; Baxter Healthcare Corporation, D
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter Healthcare Corporation
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthcare Corporation, Dee
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthc
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
BRZK993120
Aug 21, 2003Baxter Healthcare Corp.
Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corporatio
Terminated
BRZNone listed
Aug 21, 2003Baxter Healthcare Corp.
Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield,
Terminated
BRZK993120

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