Home / Recalls / Windstone Medical Packaging, Inc. / Z-1080-2024

Z-1080-2024 Class I Ongoing

Recalled by Windstone Medical Packaging, Inc. — Billings, MT

Recall Details

Product Type
Devices
Report Date
February 28, 2024
Initiation Date
December 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
128 kits

Product Description

Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

Reason for Recall

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Distribution Pattern

US: FL, IL, CA OUS: None

Code Information

UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582

Other recalls by Windstone Medical Packaging, Inc.

  • Z-0027-2025 Class II — Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem (August 16, 2024)
  • Z-0029-2025 Class II — Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem (August 16, 2024)
  • Z-0028-2025 Class II — Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Sa (August 16, 2024)
  • Z-0031-2025 Class II — Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem (August 16, 2024)
  • Z-0030-2025 Class II — Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Sale (August 16, 2024)
  • Z-1079-2024 Class I — Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO (December 22, 2023)
  • Z-1081-2024 Class I — Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO (December 22, 2023)
  • Z-1082-2024 Class I — Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO (December 22, 2023)
  • Z-1621-2023 Class II — Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light (April 24, 2023)
  • Z-1619-2023 Class II — Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Lig (April 24, 2023)