Skip to content

Electri-Cool II Portable Cold Therapy Unit, Model Number… recallZ-0496-2022 · Gentherm Medical, LLC · initiated Nov 22, 2021

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Gentherm Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

FDA root cause category: Device Design

What the company is doing

URGENT Medical Device Recall notification letters dated 11/19/21 were sent to customers. Pad Instructions: 1. Read and understand operation manual before connecting paCI to Etectri-Cool II. 2. Read and understand pad application instructions accompanying GENTHERM pad. 3. Connect hose to unit by inserting connectors on hose into connectors on unit. Connectors should "click" as they lock together. 4. Apply pad to patient and attach pad to hose by inserting connectors on pad into hose connectors. Normal use of the pad is to be applied in direct contact with the patient. Pad may be used over or under a patient, in the flat state or wrapped around patient. 5. Turn unit "ON" and set to temperature. 6. After pad has filled, check water level in unit. Add sterile water or water that has been passed through a filter less than or equal to 0.22 microns, only if necessary. 7. When therapy needs to be paused, disconnect the pad from the Electri-Cool II and allow the unit to continue to run. NOTE: Reconnect the pad when ready to resume therapy. 8. When therapy is no longer needed disconnect pad from hose by pressing metal clips. Dispose of pad. 9. Tum unit "OFF" at the power switch and unplug the power cord from the outlet. INSTRUCTIONS TO CUSTOMERS: 1) Immediately examine your inventory and add this letter and/or Appendix B to Electri-Cool II manual. 2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice. 3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to [email protected], or mail to: Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 This recall should be carried out to the user level. Your assistance is appreciated and necessary to reduce potent

Recall details

Recall number
Z-0496-2022
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 22, 2021
Recalling firm
Gentherm Medical, LLC
Quantity
484 devices
Product code
ILO
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.

Product description

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Code information (models, lots, serial numbers)

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page