RecallRadar

FDA Device recall Z-2157-2014

Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac…

On 2014-08-13 the FDA classified a Class II recall of Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac… by Icu Medical, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2157-2014
ClassificationClass II
Statusterminated
Initiated2014-07-18
Published2014-08-13
Last updated2026-09-13 11:53 UTC
CompanyIcu Medical
DistributionOR

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.

Reason

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.

Identifiers

code_infoLot No. 2886730

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2014%22

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