Tablo(R) Hemodialysis System recallZ-1485-2024 · Outset Medical, Inc. · initiated Mar 6, 2024
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Outset Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
FDA root cause category: Device Design
What the company is doing
On 3/6/24, correction notices were mailed to customers who were informed that the firm has qualified silicone tubing manufactured with a platinum initiator (platinum-cured) replacement to eliminate the presence of NDL-PCBAs. Field Service Engineers service starting in March 2024. Customers were asked to do the following: 1) Disseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred. 2) Identify and notify your home patients that were shipped or may have been shipped affected product. 3) Affected devices can be used until serviced. If you have new affected hemodialysis system(s), consider using other alternative machines, if any are available. If you only have new hemodialysis systems available to use, continue to use them so that your patients have access to dialysis treatment. Devices starting with serial number 604572M were manufactured with platinum-cured tubing and are not affected. 4) Complete and return the acknowledgement and receipt form via email to [email protected] If you have questions contact the Technical Support team at 844-698-2256
Recall details
- Recall number
- Z-1485-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 6, 2024
- Posted by the FDA
- Apr 12, 2024
- Recalling firm
- Outset Medical, Inc.
- Quantity
- 919
- Product code
- KDI
- FDA submissions
- K233335
- Distribution
- US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE
Product description
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Code information (models, lots, serial numbers)
Show the full code information (8k characters)
UDI-DI: 0850001011112 and 00850001011204. 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Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tablo(R) Hemodialysis System PN-0006000Outset Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System4 recalls8 deaths46 reports
- Tablo(R) Hemodialysis System PN-0003000Outset Medical, Inc. · Subsystem, Water Purification3 recalls34 deaths83 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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