--- title: "Aligned Medical Solutions: Convenience kits containing saline — FDA announcement Jan 23, 2024 | Is It on Recall" description: "Product cannot be verified as having the required sterility assurance level" url: https://isitonrecall.com/recall/fdapress-6a0f6c3e12f2ceed-aligned-medical-solutions-convenience-kits-containing-saline/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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 [Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-nurse-assist) ## 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. **FDA company announcement, table 1** | Brand | Aligned Medical Solutions | Aligned Medical Solutions | 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-nurse-assist). ## 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](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/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. ## What to do next Customers who have affected product[s] should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement product if needed at 406.259.6387. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, quarantined, and disposed of pursuant to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s]. Customers with questions may contact the company via telephone at 1-800 -637-7056 between the hours of 8:00 am and 5:00 pm (Mountain Time). Customers may also contact the company via e-mail at fieldcorrectiveaction@alignedmedicalsolutions.com. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-nurse-assist) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Aligned Medical Solutions records](https://isitonrecall.com/brand/aligned-medical-solutions/)