Set, Blood Transfusion
General Hospital · 21 CFR 880.5440
Recent MDR events
1,836 adverse event reports on file
- Blood Recipient SetJul 27, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02429
- Blood Recipient SetJul 27, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02430
- BLOOD RECIPIENT SETJul 15, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02334
- BLOOD RECIPIENT SETJul 10, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02289
- INTERLINKJun 30, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02197
- BLOOD RECIPIENT SETJun 25, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02126
- BLOOD RECIPIENT SETJun 18, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02084
- CLEARLINKJun 18, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02088
- CLEARLINK BLOOD RECIPIENT SETJun 15, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02002
- BLOOD RECIPIENT SETJun 12, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01988
Event type breakdown
Recalls
24 recall events for this product code
- Genesis BPS, LLC.TerminatedSep 18, 2014
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Z-2667-2014 · View FDA record ↗ - Genesis BPS, LLC.TerminatedSep 18, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Z-2668-2014 · View FDA record ↗ - Genesis BPS, LLC.TerminatedSep 18, 2014
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Z-2669-2014 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1850-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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 t
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1851-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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;
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1852-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1853-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1854-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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 Inquiri
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1855-2013 · View FDA record ↗ - Hospira Inc.TerminatedAug 5, 2013
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; P
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Z-1856-2013 · View FDA record ↗
Registered firms
40 firms currently registered for this product code
Sistemas Medicos Alaris, S.a De C.v.
TIJUANA Baja California, MX
Carefusion 2200, Inc.
Vernon Hills, IL, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Cbr Enterprise Limited
Hong Kong, HK
Medi.plan Gmbh & Co. Kg
Dortmund North Rhine-Westphalia, DE
Sterigenics U.s., Llc
Charlotte, NC, US
Baxter Healthcare, S.a.
Haina San Cristobal, DO
Sterigenics U.s., Llc
Atlanta, GA, US
Tam Viet Distribution Company Limited
HO CHI MINH, VN
Fenwal, Inc.
LAKE ZURICH, IL, US
Km Medical
North York Ontario, CA
Baxter Productos Medicos, Ltda.
1-7052 Cartago, CR
Sterigenics U.s., Llc
Queensbury, NY, US
Baxter Limited
Marsa, MT
Sterigenics Us Llc
West Memphis, AR, US
Carefusion
San Diego, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Sterigenics Costa Rica S.r.l.
El Coyol Alajuela, CR
Fenwal International, Inc.
HAINA San Cristobal, DO
Douglas Medical Products, Inc
Mundelein, IL, US
510(k) clearances
30 clearances for this product code
- Baxter Healthcare CorporationNov 17, 2022
K220558 · Blood Administration Sets
- Baxter Healthcare CorporationJun 10, 2021
K210335 · Blood Administration Set
- Arteriocyte Medical Systems, Inc.Oct 4, 2013
K132905 · 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
- Shan Dong Wei Gao Group Medical Polymer ProductsApr 10, 2009
K083349 · BLOOD TRANSFUSION SET
- Fenwal, Inc.Mar 3, 2008
K073339 · BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
- Pentaferte S.P.AJun 30, 2005
K041496 · PENTATRASFU BLOOD TRANSFUSION SETS
- Blood Products Specialties, LLCJun 20, 2005
K050805 · 30 ML OR 60 ML PEDI-SYRINGE FILTER
- Cardinal Health, Alaris ProductsApr 1, 2005
K050115 · BLOOD HAND PUMP ADMINISTRATION SET