Fresenius Medical Care Holdings, Inc. recalls 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false…
Read the official notice →- Date
- 2022-12-28
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models:…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-10-18
USFresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice →- US
Fresenius Medical Care Holdings, Inc. recalls 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
There is a potential for blood backfill leakage and foreign material.
- 2023-06-07
- US
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,…
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed to 32 clinics in SC, NC and VA.Official notice → - 2022-12-14
- US
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed Nationwide in the USA.Official notice → - 2022-11-16
- US
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA…Official notice → - 2022-10-26
- US
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Other drugs & medical recalls in the United States
- 2022-12-28
- US
NuVasive Inc recalls X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
FDA · DeviceNuVasive IncWorldwide - U.S. Nationwide distribution including in the states of NC, CA,…Official notice → - US
Howmedica Osteonics Corp. recalls Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:…
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Turkey.Official notice → - US
Natus Medical Incorporated recalls The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to…
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and…
FDA · DeviceNatus Medical IncorporatedU.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID,…Official notice → - US
GE Medical Systems, LLC recalls B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that…
- US
Icotec Ag recalls VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring…
- US
Corin Ltd recalls Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.Official notice →