Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Recall date

March 11, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1919-2026

FDA classification

Class II

Brand / firm

Windstone Medical Packaging, Inc.

Sold / distributed

US Nationwide distribution in the states of GA, OR, TN, and WA.

Why it was recalled

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433