Fresenius Medical Care Holdings, Inc. recalls US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is…
Read the official notice →- Date
- 2024-06-19
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, IN, AK, WI.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Fresenius Medical Care Holdings recalls
- 2024-09-18
USFresenius Medical Care Holdings, Inc. recalls Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the…
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Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set,…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- 2024-07-17
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Fresenius Medical Care Holdings, Inc. recalls RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution. International: Canada.Official notice → - 2024-05-29
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Fresenius Medical Care Holdings, Inc. recalls Blood Pump Rotor, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- 2024-05-22
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Fresenius Medical Care Holdings, Inc. recalls Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during…
- 2024-04-03
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Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Adapter 4 in
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice →
Other drugs & medical recalls in the United States
- 2024-06-26
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Eugia US LLC recalls Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics…
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
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Young Dental Manufacturing I, LLC recalls Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
FDA · DeviceYoung Dental Manufacturing I, LLCUS Nationwide distribution in the state of TN.Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator…
Potential for positively biased results due to signal reduction over shelf life.
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Aesculap Inc recalls Aeos Robotic Digital Microscope, Product Code: PV010
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
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Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally…
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FDA · DeviceBlue Belt Technologies, IncNationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China,…Official notice →