Windstone Medical Packaging, Inc. Recall 95306
Description: 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.
Windstone Medical Packaging, Inc. Recall 95306 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0029-2025 |
| Event ID | 95306 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY. |
| Quantity | 60 packs |
| Recall Reason | Due to convenience kits containing a kit component that is under a recall action for improper use. |
| Device Classification | 20241016 |
| Device Code Info | Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273 |
| Center Classification Date | 20241008 |
| Recall Initiation Date | 20240816 |
| Recalling Firm | Windstone Medical Packaging, Inc. |
| Initial Notification | Letter |
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