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U.S. Department of Health and Human Services

Class 2 Device Recall Transpac Trifurcated monitoring kit with Safeset Reservoir

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 Class 2 Device Recall Transpac Trifurcated monitoring kit with Safeset Reservoirsee related information
Date Initiated by FirmJuly 18, 2014
Date PostedAugust 07, 2014
Recall Status1 Terminated 3 on September 25, 2014
Recall NumberZ-2160-2014
Recall Event ID 68971
510(K)NumberK061573 
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
ProductTrifurcated 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.
Code Information Lot No. 2848741, 2859329, 2862831, 2869453
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information ContactRobert Reese
801-264-1732
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionICU 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 in Commerce60 units
DistributionWorldwide Distribution - USA including Oregon and Internationally to Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRS
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