Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius…
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Read the official notice →- Date
- 2022-09-28
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number:…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-12-14
USFresenius 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.
- 2022-08-03
- US
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on…
- 2022-07-20
- US
Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for…
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- US
Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ…
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device.…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NC and WV.Official notice →
Other drugs & medical recalls in the United States
- 2022-09-28
- US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Product may contain the incorrect material which could impact treatment.
- US
Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV,…
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of WV, NC.Official notice → - US
Diversatek Healthcare recalls Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps,…
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
- US
GELITA MEDICAL GMBH recalls ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
- US
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries Canada and Australia.Official notice → - US
CAREFUSION recalls BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may…
FDA · DeviceCAREFUSIONUS: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC,…Official notice →