Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack
- Recalling company
- Windstone Medical Packaging, Inc.
- Product
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
- Reason
- The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 29, 2026
- Reported
- Sep 16, 2026
- Distribution
- US Nationwide distribution in the states of CA, GA, WA.
- Status
- Ongoing
- Quantity
- 3,260 kits
- Lot / codes
- UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444, 237443, 236863, 236740, 236250, 236249, 236111, 235602, 235601, 235442, 235026, 235025, 235024, 235023, 234889, 234839, 234458, 233931, 233930, 233762, 233328, 233224, 231945, 231124, 231123, 231122, 231081, 231080, 230970, 230969, 230968, 230697, 230696, 230695, 230694, 230098, 229977, 229825, 229824, 229656, 229655, 229565, 229390, 229238, 229141, 229140, 228793, 228718, 228572, 228263, 227828, 227540, 227112, 226969, 226897, 226841, 226714, 226572, 226382, 225455, 225276, 225275, 223916, 223915, 223914, 223913
- Company location
- Billings, MT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3138-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3138-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.