Fresenius Medical Care Holdings, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 0 Recalls: 12

Known Identifiers & Locations

FEI Numbers 3001451489, 3002654698, 3003464075
Owner Operator Numbers 10061218
Locations Covered LAWRENCE, MA, US; TIJUANA Baja California, MX

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
3003464075 NXSTAGE MEDICAL, INC. LAWRENCE, MA, US Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details
9616074 MEDIMEXICO, S. DE R.L. DE C.V. TIJUANA Baja California, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (12)

Recall # Product Description Initiation Date Status Action
Z-0005-2024 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case Reason: There is a potential for blood backfill leakage and foreign material. 2023-08-08 Open, Classified View Details
Z-0006-2024 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case Reason: There is a potential for blood backfill leakage and foreign material. 2023-08-08 Open, Classified View Details
Z-0007-2024 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case Reason: There is a potential for blood backfill leakage and foreign material. 2023-08-08 Open, Classified View Details
Z-0028-2024 2008T Hemodialysis SYS, with CDX Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0029-2024 2008T Hemodialysis System without CDX Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0030-2024 2008T Hemodialysis System w/Bibag Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0031-2024 2008T GEN 2 Bibag without CDX Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0032-2024 2008T HD SYS. CDX BLUESTAR Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0033-2024 2008T HD SYS. CDX W/BIBAG BLUESTAR Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0034-2024 2008T HD SYS. W/O CDX BLUESTAR Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0035-2024 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR Reason: Potential PCBA leaching from tubing of hemodialysis machines. 2023-09-06 Open, Classified View Details
Z-0041-2026 Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM Reason: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap. 2025-08-29 Open, Classified View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.