Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
FDA device recall Z-1485-2024 · posted 2024-04-12 · Open, Classified
Recall details
- Recalling firm
- Outset Medical, Inc.
- 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.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 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
- Date initiated
- 2024-03-06
- Date posted
- 2024-04-12
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tablo® Hemodialysis System (K233335) | Outset Medical, Inc. | 2023-12-05 |