Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in

FDA device recall Z-0028-2025 · posted 2024-10-08 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Due to convenience kits containing a kit component that is under a recall action for improper use.

Action taken

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 inventory for the affected kits, all lots are impacted 2. Communicate the change to the use instructions with all personnel that utilize Salem Sump" products contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product correction. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Correction Response Required form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. For questions or concerns, contact Aligned Medical Solutions at fieldcorrectiveaction@alignedmedicalsolutions.com

Root cause

Use error

Status

Open, Classified

Product code

LRO

Quantity affected

894 kits

Distribution

U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Date initiated

2024-08-16

Date posted

2024-10-08

Location

Billings, MT