Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
FDA Recall #Z-1079-2024 — Class I — December 22, 2023
Product Description
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Recalling Firm
Windstone Medical Packaging, Inc. — Billings, MT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1,528 units
Distribution
US: FL, IL, CA OUS: None
Code Information
DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated