FDAFDA · Food and drugs·Recall number 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 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.
Published August 13, 2014 · Recall initiated: July 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide Distribution - USA including Oregon and Internationally to Australia.
- Lot
- Lot No. 2886730
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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