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,…
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Outset Medical
- Product
- TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2024-04-24
- US
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…
FDA · DeviceOutset Medical, Inc.US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, 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
- 2024-06-26
- US
C.R. Bard Inc recalls Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control…
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
FDA · DeviceC.R. Bard IncDistribution was nationwide. There was no government/military/foreign…Official notice → - US
Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
FDA · DeviceBaxter Healthcare CorporationDistribution was made nationwide. There was also government/military…Official notice → - US
Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
FDA · DeviceEthicon, Inc.Worldwide distribution - US Nationwide including PR and the countries of AR,…Official notice → - US
ZOLL Medical Corporation recalls ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows:…
Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from…
FDA · DeviceZOLL Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - US
Hamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR,…Official notice →