Infusor, Pressure, For I.v. Bags
General Hospital · 21 CFR 880.5420
Recent MDR events
508 adverse event reports on file
- MEDLINEJun 22, 2026MalfunctionMedline Industries, Lp1417592-2026-02920
- MEDLINEJun 2, 2026MalfunctionMedline Industries, Lp1417592-2026-01988
- MEDLINEMay 21, 2026MalfunctionMedline Industries, Lp1417592-2026-01591
- MAGNESIUM SULFATEApr 1, 2026Malfunction3010254278-2026-00006
- MAGNESIUM SULFATEApr 1, 2026MalfunctionAmneal Pharmaceuticals Pvt. Ltd., Parenteral Unit3010254278-2026-00007
- MAGNESIUM SULFATEMar 30, 2026MalfunctionAmneal Pharmaceuticals Pvt. Ltd., Parenteral Unit3010254278-2026-00003
- EthoxMar 5, 2026MalfunctionSunmed Holdings Llc1314417-2026-00009
- MEDLINEFeb 12, 2026InjuryMedline Industries, Lp1417592-2026-00113
- REPLACEABLE PRESSURE INFUSOR BAGJan 26, 2026MalfunctionMerit Medical Systems, Inc.MW5182766
- REPLACEABLE PRESSURE INFUSOR BAGJan 26, 2026MalfunctionMerit Medical Systems, Inc.MW5182767
Event type breakdown
Recalls
14 recall events for this product code
- GE Healthcare, LLCTerminatedJun 24, 2011
Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc.
Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.
Z-2663-2011 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedDec 14, 2009
Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag CATALOG NUMBER PIB500 Used to apply pressure to a sealed bag of steril
Potential sterility breach caused by excessive shipment damage.
Z-0523-2010 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0461-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0462-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor with aneroid gauge and stopcock valve.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0463-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0464-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor with aneroid gauge and stopcock valve.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0465-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0466-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0467-2009 · View FDA record ↗ - CAS Medical Systems, Inc.TerminatedDec 29, 2008
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Z-0468-2009 · View FDA record ↗
Registered firms
85 firms currently registered for this product code
Sunmed Ap, Ltd.
ZHUHAI Guangdong, CN
Sunmed Ap, Ltd., Warehouse No. 2
ZHUHAI Guangdong, CN
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Sugih Instrumendo Abadi, Pt
Bandung Barat Jawa Barat, ID
Covidien
Lafayette, CO, US
Suzhou Minhua Medical Equipment Co.,ltd.
SuZhou Jiangsu, CN
Gcmedica Enterprise Ltd.(wuxi)
WUXI Jiangsu, CN
Icu Medical, Inc.
DUBLIN, OH, US
Wenzhou Caretek Medical Device Co., Ltd
Wenzhou Zhejiang, CN
Icu Medical, Inc
Salt Lake City, UT, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Ningbo Kk-bioscience Co., Ltd.
Ningbo Zhejiang, CN
Sterigenics U.s., Llc
Atlanta, GA, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Renu Medical, Inc.
EVERETT, WA, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Med-linket Corp
Alhambra, CA, US
Pt Newlife Healthcare International
Kota Administrasi Jakarta Utara, ID
Medical Solutions, Inc.
CHANTILLY, VA, US
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Solventum Us Llc
San Antonio, TX, US
Iimed Medical Mexicana S. De R.l. De C.v.
Reynosa Tamaulipas, MX
Amis (xiamen) Cultural Creativity Co., Ltd
Xiamen Fujian, CN
Shanghai Gaohui Rubber And Plastic Products Co., Ltd
Shanghai, CN
510(k) clearances
35 clearances for this product code
- Infusion Dynamics, Inc.Feb 17, 1998
K974074 · INFUSION DYNAMICS POWER INFUSER
- Smith Assoc.Oct 29, 1997
K973843 · MSI PRESSURE INFUSOR
- Olympus America, Inc.Oct 7, 1995
K953290 · OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
- Promedic, Inc.Jun 14, 1995
K951988 · PRESSURIZER
- Circulatory Technology, Inc.Aug 25, 1994
K942933 · PRESSURE INFUSION CUFF
- Kawasumi Laboratories Co., Ltd.Dec 14, 1993
K930012 · KAWASUMI LABORATORIES K-CUFF
- Allen Medical Systems, Inc.Apr 21, 1993
K921168 · ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
- Biomedical Dynamics, Inc.Jan 9, 1992
K913751 · PRESSURE INFUSER