Tubing, Fluid Delivery
General Hospital · 21 CFR 880.5440
Recent MDR events
850 adverse event reports on file
- MEDEXJul 15, 2026MalfunctionIcu Medical, Inc.25826196
- MEDEX 4-WAY STOPCOCK EXTENSION SETJul 10, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00144
- MEDEX 4-WAY STOPCOCK EXTENSION SETJul 10, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00146
- MEDEX 4-WAY STOPCOCK EXTENSION SETJul 10, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00145
- ADMINISTRATION SETJun 2, 2026MalfunctionVygon Usa2245270-2026-00070
- PRESSURE MONITOR TUBINGMay 27, 2026MalfunctionMerit Maquiladora Mexico, S. De R.l. De C.v.3011642792-2026-00076
- MEDEX 4-WAY STOPCOCK EXTENSION SETMar 3, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00040
- MEDEX 3-WAY STOPCOCK EXTENSION SETFeb 23, 2026InjuryIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00036
- MEDEX 3-WAY STOPCOCK EXTENSION SETFeb 17, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.1526863-2026-00020
- MEDEX 3-WAY STOPCOCK EXTENSION SETFeb 17, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.1526863-2026-00021
Event type breakdown
Recalls
28 recall events for this product code
- Merit Medical Systems, Inc.Open, ClassifiedAug 12, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Z-2293-2025 · View FDA record ↗ - Hospira Inc.TerminatedJan 11, 2017
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free
Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
Z-1016-2017 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product code: 340-4114, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1659-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4115, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1660-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, product code: 340-4126, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1661-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1662-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128-V, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1663-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1664-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130-V, Method of Sterilization using Ethylene Oxide.
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1665-2012 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedMay 30, 2012
Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly, product code: 340-4137, Method of Sterilization using Et
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Z-1666-2012 · View FDA record ↗
Registered firms
82 firms currently registered for this product code
Isomedix Operations Inc.
SAN DIEGO, CA, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Isomedix Operations, Inc.
Temecula, CA, US
Medtronic Minimed
NORTHRIDGE, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Isomedix Operations Inc.
Chester, NY, US
Biomerics Cartago
Cartago, CR
Bayer Medical Care Inc.
INDIANOLA, PA, US
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Degania Silicone, Ltd.
DEGANIA BET Northern, IL
Centurion Medical Products, Lp
Williamston, MI, US
Centerpiece S. De R.l De C.v
Playas de Rosarito Baja California, MX
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Sterigenics Us Llc
Los Angeles, CA, US
Sterigenics Us Llc
West Memphis, AR, US
Merit Medical Canada Ltd.
Markham Ontario, CA
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Icu Medical Costa Rica Ltd.
La Aurora de Heredia, CR
Vygon Usa
Lansdale, PA, US
Vincent Medical (dong Guan) Manufacturing Co., Ltd.
Dong Guan City Guangdong, CN
510(k) clearances
64 clearances for this product code
- Medrad, Inc. / Bayer Medical Care, Inc.Aug 2, 2013
K131517 · MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
- Coeur, Inc.Feb 9, 2007
K063114 · DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
- Hospira, Inc.Dec 11, 2006
K063239 · LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
- Medtronic MinimedNov 29, 2005
K052431 · MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- E-Z-Em, Inc.Jul 16, 2004
K041178 · EMPOWER TRANSFER SET, (CAT. NO. 7725)
- Medrad, Inc.Jul 11, 2003
K031808 · MEDRAD SWABBABLE VALVE TRANSFER SET
- Medrad, Inc.Sep 5, 2002
K022431 · MEDRAD TRANSFER SET
- Medtronic MinimedFeb 26, 1997
K965208 · POLYFIN EXTENSION SET, MODELS 126 AND 128