Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Reported: February 28, 2024 Initiated: December 22, 2023 #Z-1081-2024
Product Description
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Details
- Recalling Firm
- Windstone Medical Packaging, Inc.
- Units Affected
- 80 kits
- Distribution
- US: FL, IL, CA OUS: None
- Location
- Billings, MT
Frequently Asked Questions
What product was recalled? ▼
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO. Recalled by Windstone Medical Packaging, Inc.. Units affected: 80 kits.
Why was this product recalled? ▼
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Critical. Recall number: Z-1081-2024.
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