WINDSTONE MEDICAL PACKAGING, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 0 Recalls: 5

Known Identifiers & Locations

FEI Numbers 1000125955, 3025686427
Owner Operator Numbers 9001641
Locations Covered BILLINGS, MT, US; Billings, MT, US

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
3025168 WINDSTONE MEDICAL PACKAGING, INC. BILLINGS, MT, US Complaint File Establishment per 21 CFR 820.198,Sterilize Medical Device for Another Party (Contract Sterilizer),Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3025686427 Windstone Medical Packaging, Inc. Billings, MT, US Repack or Relabel Medical Device,Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198 View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (5)

Recall # Product Description Initiation Date Status Action
Z-0027-2025 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use. 2024-08-16 Open, Classified View Details
Z-0028-2025 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use. 2024-08-16 Open, Classified View Details
Z-0029-2025 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use. 2024-08-16 Open, Classified View Details
Z-0030-2025 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use. 2024-08-16 Open, Classified View Details
Z-0031-2025 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use. 2024-08-16 Open, Classified View Details

Profile Disclaimer

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