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.
FDA Recall Z-2160-2014 · Posted 2014-08-07
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDRS
Date Initiated2014-07-18
Date Terminated2014-09-25
Product Quantity60 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA including Oregon and Internationally to Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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