Z-1079-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- December 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,528 units
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.
Distribution Pattern
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