Tablo Hemodialysis System recalled for PCB contamination in tubing
Outset Medical is recalling Tablo Hemodialysis Systems because their silicone tubing may contain unremoved polychlorinated biphenyl acids (PCBAs), which could cause skin conditions, liver damage, reproductive harm, or cancer.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. No reported illnesses or injuries are mentioned in the source text, but the recall involves potential exposure to harmful chemicals in a critical medical device used in dialysis treatment.
Plain-English summary
Outset Medical, Inc. is recalling Tablo Hemodialysis Systems (reference numbers PN-0003000, PN-0006000, and PN-0007001). The systems contain pre and post-dialyzer peroxide-cured silicone tubing that may contain non-dioxin-like polychlorinated biphenyl acids (PCBAs) that have not been fully flushed out with normal usage.
Exposure to PCBAs could cause skin conditions, liver damage, impaired reproduction, or development of certain cancers in humans. The recall affects 919 units distributed throughout the United States and to Armed Forces facilities overseas.
The recalled product
- Product
- Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
- Manufacturer
- Outset Medical, Inc.
- Category
- Medical Device — Hemodialysis
- Affected units
- 919
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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