Windstone Medical Packaging, Inc.: Aligned Medical AMS16835 Fluids Kit RX
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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
- Aligned Medical AMS16835 Fluids Kit RX
- Reason / hazard
- Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of IL, VA.
- Recall initiated
- 2026-04-27
- Code info
- UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
- Product quantity
- 875 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Billings
- State
- MT
- Country
- United States
- Event id
- 98957
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