Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Summary
The FDA issued a Class I for Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 by Outset Medical, Inc.. Reason: Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain.
Details
Source
Device Recall
External ID
Z-1485-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Lot/Code Info: 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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604020M, 604028M, 604029M, 604037M, 604041M, 604043M, 604046M, 604048M, 604050M, 604051M, 604052M, 604054M, 604055M, 604056M, 604058M, 604062M, 604063M, 604064M, 604067M, 604070M, 604071M, 604074M, 604075M, 604079M, 604080M
Quantity Affected: 919
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-06
Company
San Jose, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Outset Medical, Inc. has 10 FDA actions in our database, including 5 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Outset Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Outset Medical, Inc. have FDA actions?
Outset Medical, Inc. has 10 FDA actions in our database, including 5 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1485-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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