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Recall Observatory FDA recall evidence

Device product

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

Z-0987-2020

January 07, 2020

Class II

Product summary

Firm
Care Essentials Pty., Ltd.
Event
Event 84541
Status
Terminated
Classification
Class II
Quantity
251
Official record key
device-enforcement:Z-0987-2020

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.