Care Essentials Pty., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0987-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 7, 2020

Date Posted: February 12, 2020

Recall Number: Z-0987-2020

Event ID: 84541

Reason for Recall:

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.

Status: Terminated

Product Quantity: 251

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.

Voluntary or Mandated:

Voluntary: Firm initiated