—#209954

Product

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.

FDA product code: OGR — Ear, Nose, And Throat Surgical Tray
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273

Why it was recalled

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

Root cause (FDA determination)

Use error

Action the firm took

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

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

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

Timeline

Recall initiated: 2024-08-16
Posted by FDA: 2024-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.