Class 2 Device Recall Cocoon Convective Warming System

• Date Initiated by Firm: January 07, 2020
• Create Date: March 03, 2020
• Recall Status: Terminated on March 22, 2023
• Recall Number: Z-0987-2020
• Recall Event ID: 84541
• 510(K)Number: K140635
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: Cocoon Convective Warming System, Product Code: CWS5000 (110V).
• 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
• Recalling Firm/ Manufacturer: Care Essentials Pty., Ltd.; 25 Slevin St; North Geelong Australia
• For Additional Information Contact: Abhay Sinha; 61-3-52771455
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by FedEx stating: URGENT- Medical Device Field Correction Dear Valued Customer: Care Essentials ( CE ) is writing to advise you that, as a precautionary measure, we are issuing a voluntary product repair of CWS4000 and CWS5000 (110V) Cocoon Convective Warming Machines devices due to a report of thermal damage to the power entry module and power cord in a hospital in Canada. The affected devices were distributed in the U.S. from the date of March 3rd, 2015. There are no reported instances of death or serious injuries. However, in order to prevent a potential risk of fire, we are undertaking the following actions: - attaching a P-clip to the power cord of the device to both reduce the risk of using power cords that are not supplied or approved by Care Essentials, as well as reducing wear and tear of the power cord connector contacts from repeated plugging and unplugging; and - updating the instructions for use ( IFU") to add warnings about avoiding unnecessary manipulation of the power cord connector, using only power cords (which have P-clips attached) supplied by Care Essentials, and not properly using a Care Essentials P-clipped power cord could lead to risk of fire. We ask that you: - Inspect devices cited in this notification letter for any damage to the power cord connector and power socket. If any damage is observed to these parts, please do not use the affected device and contact the undersigned for repair or replacement. - Ensure that this communication, including the updated IFU with highlighted revisions, is shared with all departments within the hospital/group of hospitals within your organization that may be using one of these devices. - Confirm receipt of this letter by email (msok@msi-healthcare.com ), or queries@careessentials.com.au) or Telephone (703-9957179). Kindly fill and return the attached form: Medical Device Field Correction R
• Quantity in Commerce: 251
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ and Original Applicant = CARE ESSENTIALS PTY LTD