Aligned Medical fluids kits contain recalled lidocaine injection
Aligned Medical AMS16835 Fluids Kits are being recalled because they include Lidocaine Hydrochloride Injection, USP that was recalled by a supplier for quality issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where kits were shipped containing a drug subsequently recalled for quality issues, a risk of harm with no injuries reported.
Plain-English summary
The Aligned Medical AMS16835 Fluids Kit, UDI-DI B098AMS168350, is being recalled. The action covers 875 kits across lots 233828, 236048, 236359, 236662, 238580, 239934 and 239935.
The stated reason is that Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in these custom convenience kits. The FDA classified the action as Class II.
Distribution was within the United States, in Illinois and Virginia. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the UDI-DI and lot numbers above, quarantine them, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Aligned Medical AMS16835 Fluids Kit RX
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Procedure kit
- Affected units
- 875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI-DI: B098AMS168350
- Lot Numbers: 233828
- 236048
- 236359
- 236662
- 238580
- 239934
- 239935
Distribution
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