CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report
TabloCart with Prefiltration Drawer PN recalled by Outset Medical
Outset Medical is recalling TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), distributed nationwide in the US. The recall was initiated on 30 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2150-2024
- FDA event ID
- 94654
- Recalling firm
- Outset Medical, San Jose, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2024
- FDA classified
- 14 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2024 | Recall initiated by company | |
| 14 Jun 2024 | Classified by FDA | +45 days |
| 26 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
Where it was distributed
US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK, MA, WV, IN, KY, AZ, LA, NE, KS, NJ, CT, NM, CO, SC, TX, PA, NY, OH.
Nationwide AlaskaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIndianaKansasKentuckyLouisianaMassachusettsMarylandNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkOhio
Questions about this recall
Is TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot) recalled?
Yes. Outset Medical recalled TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot) on 30 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2150-2024.
Why was it recalled?
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
Which lots are affected?
UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747
Where was it sold?
US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK, MA, WV, IN, KY, AZ, LA, NE, KS, NJ, CT, NM, CO, SC, TX, PA, NY, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Outset Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tablo Console recalled by Outset Medical | Outset Medical | Packaging Defects | 46 states |
| Device | CLASS I | Tablo Hemodialysis System recalled by Outset Medical | Outset Medical | Other | 42 states |
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| Device | CLASS II | Outset Tablo Console recalled by Outset Medical | Outset Medical | Other | Nationwide |
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