FDAClass II · Medical device · Recalled April 29, 2026

Custom Convenience Kits Pre Op Kit - NS recall — Windstone Medical Packaging, Inc.

Hazard: 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: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1919-2026
Brand: Windstone Medical Packaging
Classification: Class II
Units affected: 475 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Custom Convenience Kits Pre Op Kit - NS

Companies & origin

Recalling firm location: Billings, MT, United States
Firm address: 1602 4th Ave N, N/A, 59101-1521

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910
Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.
Firm notified the public via: E-Mail
FDA event ID: 98659
Recall initiated: March 11, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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