AMS Convenience Kit recall
Windstone Medical Packaging, Inc. recalled AMS Convenience Kit on September 16, 2026 because of 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. It was sold nationwide.
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.
What's recalled
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Quantity: 3,260 kits
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Windstone Medical Packaging, Inc., Billings, MT
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of CA, GA, WA. - Status
- Ongoing
- Recall number
- Z-3138-2026
- Source
- U.S. Food and Drug Administration
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