Device recall
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
- Recall number
- Z-3138-2026
- Event id
- 99658
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Windstone Medical Packaging, Inc.
- Report date
- Sep 16, 2026
- Posted
- Sep 10, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Sep 10, 2026
- Product code
- KDD
- Device type
- Kit, Surgical Instrument, Disposable
- 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.
- Root cause
- Equipment maintenance
- Quantity
- 3,260 kits
- Code info
- 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
- Distribution
- US Nationwide distribution in the states of CA, GA, WA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Billings, MT, United States