FDA-Device2024-02-28Class I
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Hazard
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Sold states
US: FL, IL, CA OUS: None
Affected count
80 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1081-2024More Windstone Medical Packaging, Inc. recalls
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- FDA-Device2026-07-08Windstone Medical AMS Preop Kit-NS recalled for bacterial contamination in alcohol prep pads
- FDA-Device2026-05-20Windstone Medical Packaging Custom Convenience Kit recalled for defective Medline Namic angiographic syringes
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