Recall archive / FDA company announcement
Aligned Medical Solutions: Convenience kits containing saline — FDA announcement Jan 23, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jan 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Convenience kits containing saline
- Reason
- Product cannot be verified as having the required sterility assurance level
- Classification
- Not supplied
- Recalling firm
- Aligned Medical Solutions
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 6a0f6c3e12f2ceed
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Brand | Aligned Medical Solutions; Kit Name | Product Code | DI Number | Lot; Local Lower Extremity Pack I | AMS10833 | B098AMS108330 | 173179, 176590, 174338, 175529, 176217, 178271, 178489, 180907, 183355, 181439, 183674, 184398, 185064, 188137, 189007, 189640, 189641, 189642, 191067, 192551, 194252, 196380, 197727, 198046, 197727, 198373, 199297; In House Ocular Pack | AMS12947 | B098AMS129470 | 192389, 194805; In House Ocular Pack | AMS12947A | B098AMS12947A0 | 192436, 192774, 196582; Closure Kit | AMS13043 | B098AMS130430 | 178114, 187325, 191102, 195504, 196502, 197864 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Brand | Aligned Medical Solutions | ||
|---|---|---|---|
| Kit Name | Product Code | DI Number | Lot |
| Local Lower Extremity Pack I | AMS10833 | B098AMS108330 | 173179, 176590, 174338, 175529, 176217, 178271, 178489, 180907, 183355, 181439, 183674, 184398, 185064, 188137, 189007, 189640, 189641, 189642, 191067, 192551, 194252, 196380, 197727, 198046, 197727, 198373, 199297 |
| In House Ocular Pack | AMS12947 | B098AMS129470 | 192389, 194805 |
| In House Ocular Pack | AMS12947A | B098AMS12947A0 | 192436, 192774, 196582 |
| Closure Kit | AMS13043 | B098AMS130430 | 178114, 187325, 191102, 195504, 196502, 197864 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Aligned Medical Solutions distributed these kits nationwide. Recalled Product(s) were manufactured from 06/02/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Jan 23, 2024
- Company announcement date
- Jan 22, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.