Reported Oct 9, 2024 · Ongoing
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is…
Outset Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Outset Medical, Inc. · 3052 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- Tablo Console
- REFPN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility
- Lot codes and dates
- UDI-DI
0085000101111200850001011204
- Serial Numbers
2,162 of 2,162 codes
400405602382M602384M602387M602400M602402M601124M601156M601102M601265M400109602248M602659M602670M602767M602769M602771M601356M602421M602403M400394601728M601730M601731M601733M601735M601736M601738M601771M601772M601774M600599M600614M600615M600620M600631M600641M600646M600648M600654M600659M601337M601357M601360M601361M601364M601368M601384M601395M601396M601422M601727M602748M600189601515M601513M601514M601517M601518M601838M
- UDI-DI
- Amount recalled
- 2,422
Where it was sold
Why it was recalled
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
This product could cause temporary or reversible health problems — stop using it.
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