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FDA (Device enforcement)Recalled 2022-03-14class ii

Augustine Temperature Management, LLC: Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction

Is my product affected?

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

  • UPC 00850011479254

Check against the official notice below — it lists the full affected range.

What happened

Augustine Temperature Management, LLC is recalling HotDog Temperature Management Controllers Models WC71, WC77, and WC77V, along with Temperature Management Controller MP Model 2083516. These devices, which are used to warm patients during surgical procedures, may experience a Power-on self-test error code "EA POST" when turned on. A total of 1,113 units have been distributed worldwide, with specific serial numbers identified in the recall.

The recall record does not specify what consumers or healthcare facilities should do regarding affected devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Details from the source

Reason for recall: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST". Distribution: Worldwide Quantity: 1113 units Lot/code info: 1) UDI/DI 00850011479254, Serial Numbers: 20080090, 20080091, 20080092, 20080093, 20080094, 20080095, 20080097, 20080098, 20080099, 20080100, 20080102, 20080103, 20090000, 20090001, 20090002, 20090003, 20090004, 20090005, 20090006, 20090007, 20090008, 20090009, 20090010, 20090011, 20090012, 20090013, 20090014, 20100075, 20100076, 20100077, 20100078, 20100079, 20100080, 20100081, 20100082, 20100083, 20100084, 20100085, 20100086, 20100087, 20100088, 20100089, 20110030, 20110031, 20110033, 20110034, 20110035, 20110036, 20110038, 20110039, 20110040, 20110041, 20110042, 20110043, 20110044, 20110045, 20110047, 20110048, 20110049, 20110050, 20110053, 20110054, 20110055, 20110056, 20110058, 20110059, 20120000, 20120001, 20120002, 20120003, 20120004, 20120005, 20120006, 20120007, 20120008, 20120009, 20120010, 20120011, 20120012, 20120013, 20120014, 20120015, 20120016, 20120017, 20120018, 20120019, 20120020, 20120021, 20120022, 20120023, 20120024, 20120025, 20120026, 20120027, 20120028, 20120029, 20120030, 20120031, 20120032, 20120033, 20120034, 20120035, 20120036, 20120037, 20120038, 20120039, 20120040, 20120041, 20120042, 20120043, 20120044, 20120090, 20120091, 20120092, 20120093, 20120094, 20120095, 20120096, 20120097, 20120098, 20120099, 20120100, 20120101, 20120102, 20120103, 20120104, 21010030, 21010031, 21010032, 21010033, 21010034, 21010035, 21010036, 21010037, 21010038, 21010039, 21010040, 21010041, 21010042, 21010043, 21010044, 21010046, 21010047, 21010048, 21010049, 21010050

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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