Recall Z-0031-2025— Windstone Medical Packaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2024-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-16
- Firm location
- Billings, MT, United States
Product description
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Reason for recall
Due to convenience kits containing a kit component that is under a recall action for improper use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.