medical Class II Updated 2020-02-12

Care Essentials Pty., Ltd. recalls Cocoon Convective Warming System, Product Code: CWS5000 (110

Recalled Product

Cocoon Convective Warming System, Product Code: CWS5000 (110V).


Hazard / Issue

Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: CWS5000 (110V) Serial Numbers: CWS5-400001-18, CWS5-400011-18, S00001, S00003, S00004, S00006, S00007, S00008, S00009, S00010, S00011, S00012, S00013, S00014, S00015, S00016, S00017, S00018, S00019, S00020, S00021, S00022, S00023, S00024, S00025, S00026, S00027, S00028, S00029, S00030, S00031, S00032, S00033, S00034, S00035, S00036, S00037, S00038, S00039, S00040, S00041, S00042, S00043, S00044, S00045, S00046, S00047, S00048, S00049, S00050, S00051, S00052, S00053, S00054, S00055, S00056, S00057, S00058, S00059, S00060, S00061, S00062, S00063, S00064, S00065, S00066, S00067, S00068, S00069, S00070, S00071, S00072, S00073, S00074, S00075, S00076, S00077, S00078, S00079, S00080, S00081, S00082, S00083, S00084, S00085, S00086, S00087, S00088, S00089, S00090, S00091, S00092, S00093, S00094, S00095, S00096, S00098, S00099, S00100, S00101, S00102, S00103, S00104, S00105, S00106, S00107, S00108, S00109, S00110, S00111, S00112, S00113, S00114, S00115. S00116, S00117, S00118, S00119, S00120, S00121, S00122, S00123, S00124, S00125, S00126, S00127, S00128, S00129, S00130, S00131, S00132, S00133, S00134, S00135, S00136, S00137, S00138, S00139, S00140, S00141, S00142, S00143, S00144, S00145, S00146, S00147, S00148, S00149, S00150, S00151, S00152, S00153, S00154, S00155, S00156, S00157, S00158, S00159, S00160, S00161, S00162, S00163, S00164, S00165, S00166, S00167, S00168, S00169, S00170, S00171, S00172, S00173, S00174, S00175, S00176, S00177, S00178, S00179, S00180, S00181, S00182, S00183, S00184, S00185, S00186, S00187, S00188, S00189, S00190, S00191, S00192, S00193, S00194, S00195, S00196, S00197, S00198, S00199, S00200, S00201, S00202, S00203, S00204, S00205, S00206, S00207, S00208, S00209, S00210, S00211, S00212, S00213, S00214, S00215, S00216, S00217, S00218, S00219, S00220, S00221, S00222, S00223, S00224, S00225, S00226, S00227, S00228, S00229, S00230, S00231, S00232, S00233, S00234, S00235, S00236, S00237, S00238, S00239, S00240, S00241, S00242, S00243, S00244, S00245, S00246, S00247, S00248, S00249, S00250, S00251, S00252
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