Reported Sep 16, 2026 · Ongoing
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521
Is this the product you have?
- AMS Convenience KitDSAEK Pack - RX, Part Number AMS12394B
- Lot codes and dates
- UDI-DIB098AMS12394B0
- Lot Numbers
83 of 83 codes
241907241223241034240904240705240633240269238361238197238146238085238084238041237957237901237843237663237444237443236863236740236250236249236111235602235601235442235026235025235024235023234889234839234458233931233930233762233328233224231945231124231123231122231081231080230970230969230968230697230696230695230694230098229977229825229824229656229655229565229390
- Amount recalled
- 3,260 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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