Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
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…
Read the official notice →- Date
- 2024-04-24
- Country
- United States
- Brand
- Outset Medical
- Product
- Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
- Classification
- Class I
- Units
- US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Outset Medical recalls
- 2024-10-09
USOutset Medical, Inc. recalls Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in…
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…
FDA · DeviceOutset Medical, Inc.US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH,…Official notice →- 2024-06-26
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Outset Medical, Inc. recalls TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
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,…
FDA · DeviceOutset Medical, Inc.US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK,…Official notice → - 2023-04-19
- US
Outset Medical, Inc. recalls Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis…
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO,…Official notice → - 2022-03-30
- US
Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE,…Official notice →
Other drugs & medical recalls in the United States
- 2024-04-24
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The failure to detect the partial obstruction in a 2.5mm sensor.
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Unexpected shutdown while operating on battery power.
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Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
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Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes…
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same…
FDA · DeviceElekta Instrument ABUS and Australia, Austria, Belgium, France, Germany, Greece, Italy,…Official notice → - US
- US