FDA Medical devices recall ·
Aligned Medical Septo Pack recall
- Recall number
- Z-0029-2025
- Date
- (initiated August 16, 2024)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60 packs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to convenience kits containing a kit component that is under a recall action for improper use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
States: California Missouri Ohio Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0029-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.