Z-0951-2017Class II

Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to...

Name: Z-0951-2017 Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to...
Creator: Natus Manufacturing Limited
Published: 2016-10-15
License: https://open.fda.gov/license/

Natus Manufacturing Limited / initiated 2016-10-15 / Terminated

FDA source

Natus Manufacturing Limited began a recall of Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while... on 2016-10-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0951-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-15
Posted: 2017-01-06
Terminated: 2019-06-24
Recalling firm: Natus Manufacturing Limited
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
Product code: LGZ Warmer, Thermal, Infusion Fluid
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 root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0951-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0951-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

Product code LGZ

K132110Class IINatus Warmette Blanket and Dual CabinetsNatus Nicolet Ireland, Ltd. / cleared 2013-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)