Fresenius Medical Care Holdings, Inc.
41 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fresenius Medical Care Holdings, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-10-18FDA-DeviceClass I2008T HD SYS. W/O CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T HD SYS. CDX W/BIBAG BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T HD SYS. CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T GEN 2 Bibag without CDX
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T Hemodialysis System w/Bibag
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T Hemodialysis System without CDX
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I2008T Hemodialysis SYS, with CDX
Potential PCBA leaching from tubing of hemodialysis machines.
- 2023-10-18FDA-DeviceClass I3ML 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.
- 2023-10-18FDA-DeviceClass I10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
There is a potential for blood backfill leakage and foreign material.
- 2023-10-18FDA-DeviceClass I10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
There is a potential for blood backfill leakage and foreign material.
- 2023-06-07FDA-DrugClass IISodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Get notified about new Fresenius Medical Care Holdings, Inc. recalls
Free weekly digest. We email when a new federal recall affects Fresenius Medical Care Holdings, Inc. or anything else in your household.
Get the Sunday Brief