FDA Recall of Custom Convenience Kits Pre Op Kit - NS
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Windstone Medical Packaging, Inc. is recalling 380 units of Custom Convenience Kits Pre Op Kit - NS due to potential issues with IV administration sets causing backflow or occlusion risks.
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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Windstone Medical Packaging, Inc. is conducting a voluntary recall of 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, and issues with priming due to occlusion.
Which Products Are Affected
The affected product is Custom Convenience Kits Pre Op Kit - NS, with Part Number AMS14994. The recall involves 380 units distributed in the states of GA, OR, TN, and WA. Specific identifiers include UDI-DI: B098AMS149940 and Lot Numbers: 220039, 221423, 224226, 224793, and 225009. The recall number is Z-1920-2026.
What You Should Do
Consumers should contact the recalling firm, Windstone Medical Packaging, Inc., for instructions on the voluntary correction, as the initial notification was via e-mail.
Why This Matters
This recall addresses potential risks associated with medical devices that could lead to adverse health consequences, highlighting the importance of ensuring safe IV administration in healthcare settings.
Source
FDA recall information for event ID 98659, available on the FDA website under recall number Z-1920-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,171 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.