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.
Read the official notice →- Date
- 2022-12-14
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12…
- Classification
- Class II
- Units
- Product was distributed Nationwide in the USA.
- Category
- Drugs & medical
- Source
- FDA · Drug
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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 →- 2022-12-28
US
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…
- 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.
- 2022-09-28
US
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
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV,…Official notice →
Other drugs & medical recalls in the United States
- 2022-12-14
US
DEWEI MEDICAL EQUIPMENT CO LTD recalls Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Products were distributed in the United States without FDA authorization or clearance.
FDA · DeviceDEWEI MEDICAL EQUIPMENT CO LTDUS Distribution in states to: CA, FL, KY, and MI.Official notice →US
RemedyRepack Inc. recalls Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ…
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
FDA · DrugRemedyRepack Inc.Product was distributed to two different customers in MI.Official notice →US
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524…
Lack of sterility assurance: Bags have the potential to leak.
- 2022-12-12
US
AlEn USA Recalls Art of Green® Laundry Detergent Products Due to Risk of Exposure to Bacteria
The recalled products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to…
- 2022-12-07
US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported…
FDA · DeviceAlcon Research, LLCWorldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice →US
Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent…
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the…