Recalling firm
Windstone Medical Packaging, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-10
Distribution
US Nationwide distribution in the states of IL, VA.
Firm state
MT
Product quantity
875 kits
Initiated by
Voluntary: Firm initiated
Reason for recall
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Product description
Aligned Medical AMS16835 Fluids Kit RX
Code / lot info
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.