ICU Medical, Inc.: ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Agency Publication Date: August 7, 2014

Affected Products

Product: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2886730

Product: Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2873662

Product: Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2841944, 2841945, 2859326, 2865873, 2869445

Product: Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2848741, 2859329, 2862831, 2869453

Product: Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2866991

Product: Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2841690, 2841691, 2859331

Product: Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2866974

Product: Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2817530, 2852405, 2869455, 2883663

Product: Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Lot No. 2837897

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68971

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 9 products (20 units; 40 units; 1,560; 60 units; 200 units; 900 units; 100 units; 640 units; 50 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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