Outset Medical, Inc.: Tablo Hemodialysis Systems Recalled Due to Toxic Chemical Leaching

What You Should Do

1. Check the serial number on your Tablo Hemodialysis System to see if it matches any of the affected units, which include serial numbers beginning with 400, 600, or ending in 'M' (such as 400028, 600031, or 604080M).
2. Verify the 'Total Usage Hours' on your device; this recall specifically targets tubing in machines that have been operated for less than 336 hours.
3. If your machine is identified as an affected unit, contact your healthcare provider or Outset Medical immediately to schedule the replacement of the pre and post dialyzer tubing.
4. You can contact Outset Medical directly for technical support and recall coordination at their San Jose headquarters or via the contact information provided in the firm's notification letter.
5. Report any adverse health effects or quality issues to the FDA's MedWatch Adverse Event Reporting program.
6. For additional questions regarding this device recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

Affected Products