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Windstone Medical Packaging, Inc.: Aligned Medical AMS16835 Fluids Kit RX

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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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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