Windstone Medical Packaging, Inc.: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
- Reason / hazard
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Recall initiated
- 2026-06-08
- Code info
- 1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.
- Product quantity
- 919 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Billings
- State
- MT
- Country
- United States
- Event id
- 99323
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