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U.S. Department of Health and Human Services

Class 2 Device Recall enFlow IV Fluid Warmer

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 Class 2 Device Recall enFlow IV Fluid Warmersee related information
Date Initiated by FirmJune 30, 2011
Date PostedAugust 19, 2011
Recall Status1 Terminated 3 on June 14, 2013
Recall NumberZ-3040-2011
Recall Event ID 59688
510(K)NumberK060537 
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
ProductenFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Code Information K060537 D071942 Serial numbers: 00110412 00110497 00111507 00111633 00111718 00111719 00111816 00111835 00110790 00110946 00111686 00111691 00111916 00111764 00111787 00111897 00111939 00112078 00112200 00111880 00111906 00111733 00111664 00111668 00111672 00111673 00111699 00111745 00111749 00111771 00111773 00111786 00111807 00111817 00111832 00111865 00111886 00111891 00111898 00111954 00111975 00111996 00111997 00112042 00112071 00112106 00111703 
FEI Number 2242551
Recalling Firm/
Manufacturer		 Vital Signs Devices, a GE Healthcare Company
20 Campus Rd
Totowa NJ 07512-1210
For Additional Information ContactMs. Gwen Braeger
262-548-2608
Manufacturer Reason
for Recall		enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
FDA Determined
Cause 2		Device Design
ActionGE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy.
Quantity in Commerce1307 units
DistributionWorldwide Distribution - USA (nationwide) and the country of Vietnam
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 = LGZ
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