Recall Z-0987-2020
Care Essentials Pty., Ltd. · initiated January 7, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Codes / lots: 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…
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 taken
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
Details
- Recall number
- Z-0987-2020
- Initiated
- January 7, 2020
- Terminated
- March 22, 2023
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 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.
- Recalling firm
- Care Essentials Pty., Ltd., North Geelong
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0986-2020 Class II | Cocoon Convective Warming System, Product Code: CWS4000 (110V).Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper… | 01/07/2020Terminated |