Windstone Medical Packaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
315 (5 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0030-2025Class IIAligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0031-2025Class IIAligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0028-2025Class IIAligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0027-2025Class IIAligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. August 16, 2024
Z-0029-2025Class IIAligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. PAugust 16, 2024
Z-1080-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEODecember 22, 2023
Z-1079-2024Class IAligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEODecember 22, 2023
Z-1081-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEODecember 22, 2023
Z-1082-2024Class IAligned Medical Solutions, Closure Kit, AMS13043, STERILEEODecember 22, 2023
Z-1620-2023Class IIAligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue SApril 24, 2023
Z-1619-2023Class IIAligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, April 24, 2023
Z-1621-2023Class IIAligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, StApril 24, 2023
Z-0881-2023Class IIVarious Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M CNovember 1, 2022
Z-1101-2022Class IIPrevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenieMarch 21, 2022
Z-0119-2022Class IMonoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following August 19, 2021
Z-1848-2021Class IIAngio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 CApril 8, 2021
Z-1849-2021Class IIAngio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid ContainApril 8, 2021
Z-0069-2018Class IIAMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.October 24, 2017
Z-1787-2017Class IIDicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a genMarch 16, 2017
Z-1789-2017Class IIENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinicalMarch 16, 2017