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U.S. Department of Health and Human Services

Class 3 Device Recall Medivance ArcticGel Neonatal Pad

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  Class 3 Device Recall Medivance ArcticGel Neonatal Pad see related information
Date Initiated by Firm June 30, 2016
Date Posted August 05, 2016
Recall Status1 Terminated 3 on June 06, 2017
Recall Number Z-2345-2016
Recall Event ID 74609
510(K)Number K142702  
Product Classification System, thermal regulating - Product Code DWJ
Product Medivance ArcticGel Neonatal Pad

The pad is designed to fit into an incubator and provide whole body cooling for patients.
Code Information Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Jeff DeSanty
401-825-8690
Manufacturer Reason
for Recall		 An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
FDA Determined
Cause 2		 Other
Action A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690.
Quantity in Commerce 64
Distribution US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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