Recall Z-0028-2025 ยท LRO General Surgery Tray
Windstone Medical Packaging, Inc.
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.
| Date | Oct 8, 2024 (initiated Aug 16, 2024) |
| Status | Open, Classified |
| Reason | Due to convenience kits containing a kit component that is under a recall action for improper use. |
| Root cause | Use error |
| Action | On 08/16/2024, the firm email an "URGENT: MEDICAL DEVICE PRODUCT CORRECTION" Letter to customers informing them that Cardinal Health is conducting a product correction for its Salem Sump PVC Tubes. These Sump PVC tubes were included in the Aligned Medical convenience kits. The correction for this Recall is an updated product label, an electronic instruction for use (eIFU). The updated labeling is to address improper use of the Sump PVC tubes which can lead to breakage of the Salem Sump Anti Reflux Valve (ARV) that increases risk to patients. Customers are instructed to: 1. Review your inve |
| Quantity | 894 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.