Recall Z-2158-2014 ยท DRS Transducer, Blood-Pressure, Extravascular
ICU Medical, Inc.
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.
| Date | Aug 7, 2014 (initiated Jul 18, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732. |
| Quantity | 40 units |
| Distribution | Worldwide Distribution - USA including Oregon and Internationally to Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT Hospira, Inc., Sep 19, 2006 |