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U.S. Department of Health and Human Services

Class 2 Device Recall Natus Warmette Blanket Cabinet and Warmette Dual Cabinet

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  Class 2 Device Recall Natus Warmette Blanket Cabinet and Warmette Dual Cabinet see related information
Date Initiated by Firm October 15, 2016
Create Date January 06, 2017
Recall Status1 Terminated 3 on June 24, 2019
Recall Number Z-0951-2017
Recall Event ID 75846
510(K)Number K132110  
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
Product Natus Warmette Blanket Cabinet and Warmette Dual Cabinet
The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
Code Information Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880.   Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.
Recalling Firm/
Manufacturer		 Natus Manufacturing Limited
IDA Business Park
GORT, Galway Ireland
For Additional Information Contact Technical Service
888-4962887
Manufacturer Reason
for Recall		 The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Natus Manufacturing Limited sent an "Urgent Field Safety Notice" letter dated April, 2016, via email. The letter described the problem and the product involved in the recall. Informed the consignees that a repair kit to correct the issue is available for repair of affected units. Requested consignees to complete the attached form and Faxto 847-949-6031 or e-mail it to Natus Quality Programs. In turn the firm will send the repair kit. For questions contact Technical Service at 888-496-2887. For questions regarding this recall call 888-496-2887.
Quantity in Commerce 31
Distribution Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.
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 = LGZ and Original Applicant = NATUS NICOLET IRELAND LTD
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