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U.S. Department of Health and Human Services

Class 1 Device Recall Tablo Hemodialysis System

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  Class 1 Device Recall Tablo Hemodialysis System see related information
Date Initiated by Firm March 06, 2024
Date Posted April 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-1485-2024
Recall Event ID 94224
510(K)Number K233335  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Code Information UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530, 400532, 400543, 400546, 400552, 400554, 400556, 400557, 400558, 400560, 400564, 400565, 400566, 400593, 400595, 400598, 400610, 400614, 400615, 400618, 400626, 400657, 400741, 400764, 400775, 400792, 400813, 400837, 400874, 400879, 400894, 400924, 400941, 400942, 400988, 401048, 401120, 401122, 600031, 600059, 600141, 600145, 600146, 600344, 600394, 600396, 600020M, 600021M, 600022M, 600023M, 600025M, 600030M, 600039M, 600095M, 600138M, 600143M, 600181M, 600259M, 600283M, 600285M, 600286M, 600354M, 600355M, 600357M, 600368M, 600373M, 600387M, 600388M, 600392M, 600447M, 600475M, 600481M, 600527M, 600537M, 600556M, 600582M, 600585M, 600587M, 600590M, 600652M, 600692M, 600720M, 600724M, 600727M, 600763M, 600849M, 600966M, 601032M, 601081M, 601095M, 601098M, 601099M, 601107M, 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Recalling Firm/
Outset Medical, Inc.
3052 Orchard Dr
San Jose CA 95134-2011
For Additional Information Contact Jennifer Sipple
Manufacturer Reason
for Recall
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 Determined
Cause 2
Device Design
Action 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 FieldActionAdvisory@OutsetMedical.com If you have questions contact the Technical Support team at 844-698-2256
Quantity in Commerce 919
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
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = Outset Medical, Inc.