AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Summary
The FDA issued a Class II for AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B by Windstone Medical Packaging, Inc.. 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).
Details
Source
Device Recall
External ID
Z-3138-2026
Action Date
2026-09-16
Status
Ongoing
Category
device
Product Description
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Lot/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
Quantity Affected: 3,260 kits
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CA, GA, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 37 FDA actions in our database, including 37 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 37 FDA actions in our database, including 37 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3138-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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