Recall of Custom Convenience Kits Pre Op Kit - NS

Source: FDA · United States

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Windstone Medical Packaging, Inc. is recalling 475 units of Custom Convenience Kits Pre Op Kit - NS due to potential issues with IV administration sets that could lead to backflow of medication.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Windstone Medical Packaging, Inc. initiated a voluntary recall for Custom Convenience Kits Pre Op Kit - NS because of a potential for backflow of medication from secondary IV containers into primary ones or other connections, as well as issues with priming due to occlusion.

Which Products Are Affected

The affected product is Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433. A total of 475 units are involved, with UDI-DI: B098AMS144330 and Lot Numbers: 204612, 206723, 210211, 213641, 216064, 222060, 224073, 225012, 236012, 236910. The products were distributed nationwide in the states of GA, OR, TN, and WA in the United States. The recall number is Z-1919-2026.

What You Should Do

Consumers should contact Windstone Medical Packaging, Inc. for instructions, as the initial firm notification was via E-Mail.

Why This Matters

This recall highlights potential risks in medical devices that could affect medication delivery, impacting patient safety in healthcare settings.

Source

FDA Recall Number Z-1919-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Windstone Medical Packaging, Inc. is recalling 475 units of Custom Convenience Kits Pre Op Kit - NS due to potential issues with IV administration sets that could lead to backflow of medication.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.