PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 13, 2014 Initiated: July 18, 2014 #Z-2157-2014

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
20 units
Distribution
Worldwide Distribution - USA including Oregon and Internationally to Australia.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by ICU Medical, Inc.. Units affected: 20 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 13, 2014. Severity: Moderate. Recall number: Z-2157-2014.