Device recall: 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure…

Class II FDA enforcement event 75491. Recall start date: 27 Sep 2016. Status in the FDA record: Terminated. Termination date: 11 Jul 2017.

Reason for recall, in the words of FDA

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

ICU Medical, Inc. started this device recall on 27 Sep 2016. The firm address in the FDA record is in San Clemente, CA. FDA put the recall in Class II. FDA event 75491 has 162 product records. The first FDA enforcement report date is 23 Nov 2016. The record gives the status Terminated, with the termination date 11 Jul 2017.

FDA enforcement report The 162 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

ICU Medical, Inc., San Clemente, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

162 product records in the event.

FDA event 75491: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0414-2017	4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	20 units	Class II	Terminated	23 Nov 2016
Z-0415-2017	TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	60,560 units	Class II	Terminated	23 Nov 2016
Z-0416-2017	Transpac IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…	130 units	Class II	Terminated	23 Nov 2016
Z-0417-2017	TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	140 units	Class II	Terminated	23 Nov 2016
Z-0418-2017	TRANSPAC IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…	260 units	Class II	Terminated	23 Nov 2016
Z-0419-2017	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	380 units	Class II	Terminated	23 Nov 2016
Z-0420-2017	TRANSPAC IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	340 units	Class II	Terminated	23 Nov 2016
Z-0421-2017	TRANSPAC IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…	260 units	Class II	Terminated	23 Nov 2016
Z-0422-2017	TRANSPAC IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure…	3060 units	Class II	Terminated	23 Nov 2016
Z-0423-2017	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	4580 units	Class II	Terminated	23 Nov 2016
Z-0424-2017	TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can…	2310 units	Class II	Terminated	23 Nov 2016
Z-0425-2017	TRANSPAC IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	520 units	Class II	Terminated	23 Nov 2016
Z-0426-2017	TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…	3640 units	Class II	Terminated	23 Nov 2016
Z-0427-2017	Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	38160 units	Class II	Terminated	23 Nov 2016
Z-0428-2017	TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42584-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…	3480 units	Class II	Terminated	23 Nov 2016
Z-0429-2017	Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	17420 units	Class II	Terminated	23 Nov 2016
Z-0430-2017	TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	800 units	Class II	Terminated	23 Nov 2016
Z-0431-2017	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	4360 units	Class II	Terminated	23 Nov 2016
Z-0432-2017	TRANSPAC IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…	1740 units	Class II	Terminated	23 Nov 2016
Z-0433-2017	TRANSPAC IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	500 units	Class II	Terminated	23 Nov 2016
Z-0434-2017	TRANSPAC IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes…	4470 units	Class II	Terminated	23 Nov 2016
Z-0435-2017	TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…	730 units	Class II	Terminated	23 Nov 2016
Z-0436-2017	Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	40 units	Class II	Terminated	23 Nov 2016
Z-0437-2017	Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	40 units	Class II	Terminated	23 Nov 2016
Z-0438-2017	Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input…	200 units	Class II	Terminated	23 Nov 2016
Z-0439-2017	TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	3460 units	Class II	Terminated	23 Nov 2016
Z-0440-2017	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	2240 units	Class II	Terminated	23 Nov 2016
Z-0441-2017	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MICRODRIP (POLE MOUNT), Item No. 42608-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	900 units	Class II	Terminated	23 Nov 2016
Z-0442-2017	TRANSPAC IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…	3020 units	Class II	Terminated	23 Nov 2016
Z-0443-2017	TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…	11100 units	Class II	Terminated	23 Nov 2016
Z-0444-2017	TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE WITH INFUSION PUMP), Item No. 42634-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…	2900 units	Class II	Terminated	23 Nov 2016
Z-0445-2017	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42640-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	280 units	Class II	Terminated	23 Nov 2016
Z-0446-2017	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	820 units	Class II	Terminated	23 Nov 2016
Z-0447-2017	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42642-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	1960 units	Class II	Terminated	23 Nov 2016
Z-0448-2017	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42643-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	200 units	Class II	Terminated	23 Nov 2016
Z-0449-2017	TRANSPAC IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42644-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	2200 units	Class II	Terminated	23 Nov 2016
Z-0450-2017	TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes…	60 units	Class II	Terminated	23 Nov 2016
Z-0451-2017	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…	1100 units	Class II	Terminated	23 Nov 2016
Z-0452-2017	TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…	740 units	Class II	Terminated	23 Nov 2016
Z-0453-2017	TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…	710 units	Class II	Terminated	23 Nov 2016
Z-0454-2017	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	1480 units	Class II	Terminated	23 Nov 2016
Z-0455-2017	Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	500 units	Class II	Terminated	23 Nov 2016
Z-0456-2017	SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input…	130 units	Class II	Terminated	23 Nov 2016
Z-0457-2017	CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure…	60 units	Class II	Terminated	23 Nov 2016
Z-0458-2017	ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	1240 units	Class II	Terminated	23 Nov 2016
Z-0459-2017	MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…	370 units	Class II	Terminated	23 Nov 2016
Z-0460-2017	CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible…	100 units	Class II	Terminated	23 Nov 2016
Z-0461-2017	ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into…	190 units	Class II	Terminated	23 Nov 2016
Z-0462-2017	KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible…	60 units	Class II	Terminated	23 Nov 2016
Z-0463-2017	DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	100 units	Class II	Terminated	23 Nov 2016
Z-0464-2017	TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input…	100 units	Class II	Terminated	23 Nov 2016
Z-0465-2017	BIFURCATED TRANSPAC 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	120 units	Class II	Terminated	23 Nov 2016
Z-0466-2017	CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible…	140 units	Class II	Terminated	23 Nov 2016
Z-0467-2017	OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	120 units	Class II	Terminated	23 Nov 2016
Z-0468-2017	TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input…	130 units	Class II	Terminated	23 Nov 2016
Z-0469-2017	ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input…	175 units	Class II	Terminated	23 Nov 2016
Z-0470-2017	PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	650 units	Class II	Terminated	23 Nov 2016
Z-0471-2017	LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible…	336 units	Class II	Terminated	23 Nov 2016
Z-0472-2017	RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure…	125 units	Class II	Terminated	23 Nov 2016
Z-0473-2017	M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…	75 units	Class II	Terminated	23 Nov 2016

The table shows 60 of 162 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 162Median of the firm: 2
Events of the firm on the register: 75

Other events of the firm

Other FDA enforcement events of ICU Medical, Inc.
Initiated	Product (first record)	Type	Class	Records
20 Aug 2026	CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Code	Device	Class II	1
24 Jun 2026	Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p	Device	Class II	1
10 Jun 2026	ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump	Device	Class II	2
12 May 2026	Plum administration sets	Device	Class II	8
29 Apr 2026	Plum Solo Precision IV Pump, 40001-0401	Device	Class II	3
24 Mar 2026	Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock	Device	Class II	1
19 Dec 2025	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000	Device	Class II	1
19 Dec 2025	Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG	Device	Class II	2
15 Dec 2025	Plum Duo Infusion System, List Number 40002-04-01	Device	Class II	1
15 Dec 2025	ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)	Device	Class II	3

ICU Medical, Inc.: all 75 events

Official channels

FDA enforcement report Z-0414-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 75491. https://recallregister.com/fda/ii/75491/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 75491?: The event has 162 product records. The first record gives this quantity: 20 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.