Recall Z-1080-2024— Windstone Medical Packaging, Inc.
Class I · Ongoing
Class I FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2023-12-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO. Reason: Sterility assurance for saline included in surgical kits cannot be guaranteed..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-22
- Firm location
- Billings, MT, United States
Product description
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Reason for recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.