Class I
Medical Device Recall: Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Windstone Medical Packaging, Inc. · December 22, 2023
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Distribution
US: FL, IL, CA OUS: None
States Affected
CA, FL, IL
Quantity Affected
475 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1082-2024
Status: ongoing
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